Henry Schein
Pack Plastics Procedure F/ Raja Mohan Plastic Surgery Center of Dallas
24manufacturers in China registered for this device type
729catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2022-01-18 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 50, case of 20 |
| Distribution end date | 2019-10-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5702890 | 10 | In distribution | |
| 8882640 | In distribution | ||
| 5702897 | 6 | In distribution | |
| 8882520 | In distribution | ||
| 8882601 | In distribution | ||
| 5701495 | 20 | In distribution | |
| 5702802 | 6 | In distribution | |
| 5702936 | 6 | In distribution | |
| 5702393 | 3 | In distribution | |
| 5703070 | 8 | In distribution | |
| 5701954 | 10 | In distribution | |
| 5703457 | 6 | In distribution | |
| 5700644 | In distribution | ||
| 5702784 | 5 | In distribution | |
| 5702892 | 3 | In distribution | |
| 5700737 | In distribution | ||
| 5702930 | 3 | In distribution | |
| 5702615 | 3 | In distribution | |
| 5703242 | 4 | In distribution | |
| 8882493 | In distribution | ||
| 5701162 | In distribution | ||
| 5703422 | 6 | In distribution | |
| 5702963 | 4 | In distribution | |
| 5700705 | 5 | In distribution | |
| 5701055 | In distribution | ||
| 5702779 | 10 | In distribution | |
| 5702739 | 4 | In distribution | |
| 5701457 | In distribution | ||
| 5701868 | 10 | In distribution | |
| 5702921 | 30 | In distribution | |
| 5702182 | 3 | In distribution | |
| 5705523 | 6 | In distribution | |
| 5703073 | 3 | In distribution | |
| 5705428 | 6 | In distribution | |
| 5701521 | In distribution | ||
| 5702936 | 12 | In distribution | |
| 5701952 | 4 | In distribution | |
| 5701157 | In distribution | ||
| 5702615 | 12 | In distribution | |
| 5703460 | 10 | In distribution | |
| 5702676 | 2 | In distribution | |
| 8882518 | In distribution | ||
| 5702689 | 5 | In distribution | |
| 5705453 | 4 | In distribution | |
| 5700679 | In distribution | ||
| 5702817 | 2 | In distribution | |
| 5702163 | 20 | In distribution | |
| 5701870 | 6 | In distribution | |
| 8882502 | In distribution | ||
| 5702793 | 8 | In distribution | |
| 5703894 | 6 | In distribution | |
| 8882552 | In distribution | ||
| 5702896 | 3 | In distribution | |
| 5702822 | 8 | In distribution | |
| 5704325 | 40 | In distribution | |
| 5702821 | 6 | In distribution | |
| 5702692 | 12 | In distribution | |
| 5705106 | 3 | In distribution | |
| 5702464 | 5 | In distribution | |
| 5703067 | 6 | In distribution | |
| 5702009 | 3 | In distribution | |
| 5702930 | 4 | In distribution | |
| 5702677 | 2 | In distribution | |
| 5700614 | In distribution | ||
| 5703835 | 8 | In distribution | |
| 5705440 | 10 | In distribution | |
| 5702277 | 5 | In distribution | |
| 5701956 | 20 | In distribution | |
| 5701513 | In distribution | ||
| 5703433 | 12 | In distribution | |
| 5702270 | 4 | In distribution | |
| 5704392 | 4 | In distribution | |
| 5702955 | 5 | In distribution | |
| 5702939 | 2 | In distribution | |
| 8882620 | In distribution | ||
| 5702391 | 3 | In distribution | |
| 5702715 | 5 | In distribution | |
| 5703879 | 8 | In distribution | |
| 5704391 | 4 | In distribution | |
| 5704216 | 12 | In distribution | |
| 5701164 | In distribution | ||
| 5700621 | 5 | In distribution | |
| 5702738 | 3 | In distribution | |
| 5703863 | 3 | In distribution | |
| 5701476 | In distribution | ||
| 5702673 | 4 | In distribution | |
| 5704224 | 16 | In distribution | |
| 5702276 | 3 | In distribution | |
| 5703304 | In distribution | ||
| 8882629 | In distribution | ||
| 5701881 | 5 | In distribution | |
| 5702819 | 6 | In distribution | |
| 5703801 | 5 | In distribution | |
| 5702885 | 2 | In distribution | |
| 8882618 | In distribution | ||
| 5705434 | 6 | In distribution | |
| 5702807 | 5 | In distribution | |
| 5703396 | In distribution | ||
| 5701161 | In distribution | ||
| 5705825 | 3 | In distribution | |
| 8882509 | In distribution | ||
| 5701498 | In distribution | ||
| 5702907 | 2 | In distribution | |
| 5705767 | 8 | In distribution | |
| 5701111 | In distribution | ||
| 5703817 | 5 | In distribution | |
| 8882604 | In distribution | ||
| 5703456 | 6 | In distribution | |
| 5702880 | 5 | In distribution | |
| 5702887 | 4 | In distribution | |
| 5702717 | 25 | In distribution | |
| 5700821 | In distribution | ||
| 5704778 | 20 | In distribution | |
| 5701957 | 20 | In distribution | |
| 5701514 | In distribution | ||
| 5702678 | 14 | In distribution | |
| 5703424 | 3 | In distribution | |
| 8882477 | In distribution | ||
| 5702811 | 10 | In distribution | |
| 5702006 | 3 | In distribution | |
| 5702719 | 8 | In distribution | |
| 5703895 | 3 | In distribution | |
| 5712011 | 20 | In distribution | |
| 5702669 | 10 | In distribution | |
| 5701118 | In distribution | ||
| 8882496 | In distribution | ||
| 5702954 | 5 | In distribution | |
| 5702681 | 10 | In distribution | |
| 8882605 | In distribution | ||
| 5705710 | 10 | In distribution | |
| 5703071 | 2 | In distribution | |
| 5702781 | 5 | In distribution | |
| 5701865 | 4 | In distribution | |
| 5702716 | 10 | In distribution | |
| 5703560 | 8 | In distribution | |
| 5703223 | 3 | In distribution | |
| 5701650 | In distribution | ||
| 5705673 | 4 | In distribution | |
| 5700605 | In distribution | ||
| 5701710 | 10 | In distribution | |
| 5702827 | 3 | In distribution | |
| 5702672 | 2 | In distribution | |
| 5704394 | 6 | In distribution | |
| 8882349 | In distribution | ||
| 5702727 | 3 | In distribution | |
| 5704323 | 6 | In distribution | |
| 5701951 | 4 | In distribution | |
| 5701492 | In distribution | ||
| 5702901 | 4 | In distribution | |
| 5703431 | 6 | In distribution | |
| 5701156 | In distribution | ||
| 5702912 | 5 | In distribution | |
| 5703305 | 8 | In distribution | |
| 5702400 | 3 | In distribution | |
| 5701690 | 3 | In distribution | |
| 5702900 | 10 | In distribution | |
| 5702827 | 4 | In distribution | |
| 5702463 | 5 | In distribution | |
| 5702951 | 5 | In distribution | |
| 5701512 | In distribution | ||
| 5703059 | 7 | In distribution | |
| 8882394 | In distribution | ||
| 8882345 | In distribution | ||
| 5702790 | 5 | In distribution | |
| 5703072 | 3 | In distribution | |
| 5702071 | 6 | In distribution | |
| 5701871 | 4 | In distribution | |
| 5702271 | 4 | In distribution | |
| 8882492 | In distribution | ||
| 8882540 | In distribution | ||
| 8882621 | In distribution | ||
| 5704223 | 5 | In distribution | |
| 5703724 | 9 | In distribution | |
| 5702938 | 5 | In distribution | |
| 5705669 | 5 | In distribution | |
| 8882629 | In distribution | ||
| 5700629 | In distribution | ||
| 5702879 | 5 | In distribution | |
| 5704799 | 6 | In distribution | |
| 5705670 | 5 | In distribution | |
| 5701155 | In distribution | ||
| 5702937 | 6 | In distribution | |
| 5704798 | 3 | In distribution | |
| 5705457 | 30 | In distribution | |
| 5703844 | 8 | In distribution | |
| 5701577 | In distribution | ||
| 5701482 | 3 | In distribution | |
| 5704389 | 5 | In distribution | |
| 5701482 | In distribution | ||
| 5701332 | In distribution | ||
| 5704770 | 10 | In distribution | |
| 5702792 | 4 | In distribution | |
| 5703508 | 5 | In distribution | |
| 5702954 | 5 | In distribution | |
| 5703468 | 20 | In distribution | |
| 8882473 | In distribution | ||
| 8882554 | In distribution | ||
| 5701159 | In distribution | ||
| 5703092 | 36 | In distribution | |
| 5702913 | 2 | In distribution | |
| 5703723 | 16 | In distribution | |
| 5702557 | 3 | In distribution | |
| 5702890 | 25 | In distribution | |
| 5704326 | 2 | In distribution | |
| 5703551 | 30 | In distribution | |
| 5702692 | 12 | In distribution | |
| 8882577 | In distribution | ||
| 5702192 | 5 | In distribution | |
| 5700600 | In distribution | ||
| 5701416 | In distribution | ||
| 5702687 | 6 | In distribution | |
| 5702883 | 8 | In distribution | |
| 8882610 | In distribution | ||
| 5703134 | 5 | In distribution | |
| 5703063 | 10 | In distribution | |
| 5702888 | 4 | In distribution | |
| 5705766 | 5 | In distribution | |
| 5705431 | 3 | In distribution | |
| 8882390 | In distribution | ||
| 5702777 | 6 | In distribution | |
| 5701503 | In distribution | ||
| 5702392 | 5 | In distribution | |
| 5703211 | 6 | In distribution | |
| 5702939 | 5 | In distribution | |
| 5701869 | 20 | In distribution | |
| 5701865 | 8 | In distribution | |
| 5704324 | 10 | In distribution | |
| 5705553 | 3 | In distribution | |
| 5702884 | 9 | In distribution | |
| 5702711 | 5 | In distribution | |
| 5702793 | 3 | In distribution | |
| 5704818 | 4 | In distribution | |
| 5701334 | 30 | In distribution | |
| 5702671 | 3 | In distribution | |
| 8882632 | In distribution | ||
| 5700705 | In distribution | ||
| 5701515 | In distribution | ||
| 5700584 | In distribution | ||
| 5702713 | 5 | In distribution | |
| 5702786 | 25 | In distribution | |
| 5702007 | 3 | In distribution | |
| 5702898 | 8 | In distribution | |
| 5703062 | 40 | In distribution | |
| 5703845 | 6 | In distribution | |
| 5702065 | 3 | In distribution | |
| 5702682 | 10 | In distribution | |
| 5705448 | 36 | In distribution | |
| 5703838 | 8 | In distribution | |
| 5703132 | 10 | In distribution | |
| 5703157 | 4 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54,362 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| Halyard | Avid Medical, Inc. | 12,802 |
| ACS | American Contract Systems, Inc. | 10,337 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Stradis | Stradis Healthcare | 685 |
| Centurion | Centurion Medical Products Corporation | 672 |
Showing 12 of 113. All products under General Surgery Tray
Recalls Naming This Product
27 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stradis Healthcare | UDI-DI | 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 1,040 units |
| Stradis Healthcare | UDI-DI | 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 21,755 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 800 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 15 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 35 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 30 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 96 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 8 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 20 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 104 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 24 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 18 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 12 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 90 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 5 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 675 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 100 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 18 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 24 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 25 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 144 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 10 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 48 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 16 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 27 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 304 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-11-02 | Class II | Packaging process control | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit. | 3 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.