Stradis Healthcare
Custom Surgical Kit- Small Procedural Trays
24manufacturers in China registered for this device type
143catalogue numbers in this listing
40recalls on this code
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 | Stradis Healthcare, 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 | 2022-03-21 |
| Record revised | 2023-01-30 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 20, case of 5, case of 25, case of 3, case of 10, case of 100 |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 570-2802 | In distribution | |
| 682-2122 | In distribution | |
| 683-126 | In distribution | |
| TAU3059 | In distribution | |
| TAU1016 | In distribution | |
| 682-2183 | In distribution | |
| 682-1926 | In distribution | |
| 570-2828 | In distribution | |
| KPX3209 | In distribution | |
| 570-3224 | In distribution | |
| 888-2629 | In distribution | |
| 682-2186 | In distribution | |
| 570-2718 | In distribution | |
| TAU1015 | In distribution | |
| 570-1494 | In distribution | |
| 570-3223 | In distribution | |
| 683-139 | In distribution | |
| KPX3064 | In distribution | |
| 670-202 | In distribution | |
| 570-2680 | In distribution | |
| TAU3047 | In distribution | |
| 618-014 | In distribution | |
| TAU3077A | In distribution | |
| 681-347 | In distribution | |
| 682-1956 | In distribution | |
| 570-2900 | In distribution | |
| 690-261 | In distribution | |
| 570-2955 | In distribution | |
| 525-043 | In distribution | |
| TAU1010 | In distribution | |
| 888-2637 | In distribution | |
| KPX4725R1 | In distribution | |
| 570-2921 | In distribution | |
| TAU3035 | In distribution | |
| 570-2927 | In distribution | |
| TAU1051 | In distribution | |
| 888-2547R1 | In distribution | |
| 670-208 | In distribution | |
| SS79888 | Withdrawn | |
| 570-0644 | Withdrawn | |
| 682-2111 | Withdrawn | |
| 525-199 | Withdrawn | |
| 601-1184 | Withdrawn | |
| 570-2223 | Withdrawn | |
| 570-1692 | Withdrawn | |
| 690-252 | Withdrawn | |
| 570-1475R1 | Withdrawn | |
| ZZ-0705 | Withdrawn | |
| 681-289 | Withdrawn | |
| 682-1336 | Withdrawn | |
| 888-2547 | Withdrawn | |
| 693-233 | Withdrawn | |
| 681-292 | Withdrawn | |
| 570-2951 | Withdrawn | |
| 682-1959 | Withdrawn | |
| 682-1991 | Withdrawn | |
| KPX3429 | Withdrawn | |
| 682-1984 | Withdrawn | |
| 682-2300 | Withdrawn | |
| 682-1930 | Withdrawn | |
| 698-001 | Withdrawn | |
| 570-2592 | Withdrawn | |
| 618-032 | Withdrawn | |
| 670-142 | Withdrawn | |
| 682-2247 | Withdrawn | |
| 570-2925 | Withdrawn | |
| 686-198 | Withdrawn | |
| 682-2140 | Withdrawn | |
| 602-121 | Withdrawn | |
| 570-2817 | Withdrawn | |
| 682-2167 | Withdrawn | |
| 570-2926 | Withdrawn | |
| 515-001 | Withdrawn | |
| 570-2914 | Withdrawn | |
| 682-2135 | Withdrawn | |
| 682-1953 | Withdrawn | |
| 570-2008 | Withdrawn | |
| 682-2135R1 | Withdrawn | |
| 888-2520 | Withdrawn | |
| 570-2963 | Withdrawn | |
| 618-014 | Withdrawn | |
| 570-1550 | Withdrawn | |
| ZZ-0685 | Withdrawn | |
| ZZ-0960 | Withdrawn | |
| 682-2298 | Withdrawn | |
| 570-2904 | Withdrawn | |
| 570-1552 | Withdrawn | |
| ZZ-0956 | Withdrawn | |
| 686-169 | Withdrawn | |
| 570-2770 | Withdrawn | |
| 695-084 | Withdrawn | |
| 682-1955 | Withdrawn | |
| 570-1913 | Withdrawn | |
| 682-2104 | Withdrawn | |
| 665-067 | Withdrawn | |
| 682-2308 | Withdrawn | |
| 570-2615 | Withdrawn | |
| 570-2071 | Withdrawn | |
| 618-005 R1 | Withdrawn | |
| 570-2463 | Withdrawn | |
| 570-2893 | Withdrawn | |
| 690-252 | Withdrawn | |
| KPX4724 | Withdrawn | |
| 888-2614 | Withdrawn | |
| 619-023 | Withdrawn | |
| 682-1995 | Withdrawn | |
| 525-200 | Withdrawn | |
| 570-2717 | Withdrawn | |
| 570-1334 | Withdrawn | |
| 682-2254 | Withdrawn | |
| 570-2719 | Withdrawn | |
| 570-3211 | Withdrawn | |
| 570-2679 | Withdrawn | |
| 570-2938 | Withdrawn | |
| 570-1551 | Withdrawn | |
| 800742003 | Withdrawn | |
| 525-120 | Withdrawn | |
| 570-2672 | Withdrawn | |
| 525-071 | Withdrawn | |
| 619-013 | Withdrawn | |
| 655-018 | Withdrawn | |
| 570-1474 | Withdrawn | |
| 888-2577 | Withdrawn | |
| 570-2811 R1 | Withdrawn | |
| 683-188 | Withdrawn | |
| 570-1954 | Withdrawn | |
| 682-1993 | Withdrawn | |
| 682-2139 | Withdrawn | |
| KPX5932 | Withdrawn | |
| 682-1979 | Withdrawn | |
| 670-189 | Withdrawn | |
| 570-3199 | Withdrawn | |
| 570-1508 | Withdrawn | |
| 665-031 | Withdrawn | |
| 682-2120 | Withdrawn | |
| 682-2231 | Withdrawn | |
| 687-553 | Withdrawn | |
| 686-182 | Withdrawn | |
| 683-123 | Withdrawn | |
| 570-2731 | Withdrawn | |
| 618-015 | Withdrawn | |
| 570-2215 | Withdrawn | |
| 570-2830 | Withdrawn |
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 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
Showing 12 of 113. All products under General Surgery Tray
Recalls Naming This Product
8 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 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. | 150 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. | 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. | 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. | 304 units |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 4 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 3 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 5 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 3 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 2 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 24 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 2 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 9 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 9 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 3 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 13 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 1 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 3 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | Two |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 4 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 2 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 6 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | 2 |
| 2015-04-20 | Class II | Nonconforming Material/Component | Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits. | One |
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.