Stradis Healthcare
Custom Convenience KIT, Oral Surgery Pack
7manufacturers in China registered for this device type
69catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | OFX |
| Device type | General Purpose Dental Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Premarket notification | Exempt |
| Record published | 2022-03-22 |
| Record revised | 2023-01-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 100, case of 10, case of 20, case of 5, case of 6, pack of 5 |
| Sizes | Width 44 in; length 60 in |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 682-120SS | In distribution | |
| 41015NSI | In distribution | |
| 40548IUS | In distribution | |
| 570-3238 | In distribution | |
| SS66952 | Width 44 in | Withdrawn |
| 997-4278 | Withdrawn | |
| 20004JHH | Withdrawn | |
| 20099SSHP (Chi) | Withdrawn | |
| 40046OSG | Withdrawn | |
| 20169GOG | Withdrawn | |
| 41086JMS | Withdrawn | |
| 20081ECD | Withdrawn | |
| 40326ROS | Withdrawn | |
| 20006ABH | Withdrawn | |
| 20061RHD | Withdrawn | |
| 41158TMS | Withdrawn | |
| 41073BNS | Withdrawn | |
| 20172GJLG | Withdrawn | |
| 40692SYK | Withdrawn | |
| 40690MSS | Withdrawn | |
| 40950HSPR1 | Withdrawn | |
| 40410DFS | Withdrawn | |
| 20168GJDT | Withdrawn | |
| 40940RSS | Withdrawn | |
| 40276BDSR1 | Withdrawn | |
| 40498WWS | Withdrawn | |
| 20053BFO | Withdrawn | |
| 20048BSRII | Withdrawn | |
| 40905MHS | Withdrawn | |
| 570-2902 | Withdrawn | |
| 20020JRH | Withdrawn | |
| 40393BUOS | Withdrawn | |
| 41027DFS | Withdrawn | |
| 570-2779 | Withdrawn | |
| 40154JZS | Withdrawn | |
| 41067BFO | Withdrawn | |
| 148-97705 | Withdrawn | |
| 20168GJDT | Withdrawn | |
| 570-2685 | Withdrawn | |
| 20167LBP | Withdrawn | |
| 41249LDSP | Withdrawn | |
| 20150DSH | Withdrawn | |
| 30083BBD | Withdrawn | |
| ZZ-1410 | Withdrawn | |
| 40618GOS | Withdrawn | |
| 40583VDS | Withdrawn | |
| 41234CHAR | Withdrawn | |
| 570-2820 | Withdrawn | |
| 20249ODP | Withdrawn | |
| 20116OMH | Withdrawn | |
| 20269HUP | Withdrawn | |
| 20114JVH | Withdrawn | |
| 60029CBP | Withdrawn | |
| 20043GDP | Withdrawn | |
| 570-2690 | Withdrawn | |
| 30084BBH | Withdrawn | |
| 40534AMS | Withdrawn | |
| 20100SSOP (Chi) | Withdrawn | |
| 20113JVD | Withdrawn | |
| 20117TOD | Withdrawn | |
| 20049BOS | Withdrawn | |
| 40242RHS | Withdrawn | |
| 60030CBP | Withdrawn | |
| 40900YGSR1 | Withdrawn | |
| 40592OMS | Withdrawn | |
| 40705GMP | Withdrawn | |
| 40926TMS | Withdrawn | |
| 863-0062 | Withdrawn | |
| 41060DAS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 813 |
| Medline Industries, Inc. | Medline Industries, Inc. | 287 |
| Stradis | Stradis Healthcare | 44 |
| Aligned Medical Solutions | Aligned Medical Solutions | 25 |
| ACS | American Contract Systems, Inc. | 25 |
| Centurion | Centurion Medical Products Corporation | 21 |
| Medical Action Industries | Medical Action Industries, Inc. | 10 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| DeRoyal | Deroyal Industries, Inc. | 3 |
| Regard™ | ROi CPS LLC | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
Showing 12 of 46. All products under General Purpose Dental Tray
Recalls Naming This Product
2 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. | 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. | 90 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.