Stradis Healthcare
Custom Surgical KIT-Orthopedic Pack
1manufacturer
66catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-02-16 |
| 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 |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 3, case of 4, case of 100, case of 5 |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 570-3200 | In distribution | |
| 570-2464 | In distribution | |
| 888-2627 | In distribution | |
| 570-3218 | In distribution | |
| 690-292 | In distribution | |
| 609-020R1 | In distribution | |
| 570-2676 | In distribution | |
| 570-2677 | In distribution | |
| 888-2518 | In distribution | |
| 693-278 | In distribution | |
| 570-2465 | In distribution | |
| 690-260 | In distribution | |
| 570-2006 | In distribution | |
| 570-3235 | In distribution | |
| 570-3231 | In distribution | |
| 570-2962 | In distribution | |
| 570-2732 | Withdrawn | |
| 570-2804 | Withdrawn | |
| 690-391 | Withdrawn | |
| 570-2674 | Withdrawn | |
| 888-2504 | Withdrawn | |
| 570-1605 | Withdrawn | |
| 570-2805 | Withdrawn | |
| MPR956 | Withdrawn | |
| SYS-030 | Withdrawn | |
| 570-2391 | Withdrawn | |
| 570-2676 | Withdrawn | |
| 570-2392 | Withdrawn | |
| 570-2808 | Withdrawn | |
| 690-263 | Withdrawn | |
| MPR100211 R2 | Withdrawn | |
| 570-2780 | Withdrawn | |
| 570-2677 | Withdrawn | |
| 570-2781 | Withdrawn | |
| MPR100211 | Withdrawn | |
| 570-2783 | Withdrawn | |
| 570-2908 | Withdrawn | |
| 570-2674 R1 | Withdrawn | |
| 570-2712 | Withdrawn | |
| 570-3266 | Withdrawn | |
| 570-2732 | Withdrawn | |
| 570-2905 | Withdrawn | |
| 570-2716 | Withdrawn | |
| 570-2784 | Withdrawn | |
| 570-2393 | Withdrawn | |
| 570-2394 | Withdrawn | |
| 888-2503 | Withdrawn | |
| 570-2671 R1 | Withdrawn | |
| 570-2917 | Withdrawn | |
| 888-2388 | Withdrawn | |
| 570-2065 | Withdrawn | |
| 570-2715 | Withdrawn | |
| 570-2713 | Withdrawn | |
| 570-2217 | Withdrawn | |
| 570-2907 | Withdrawn | |
| MPR955 | Withdrawn | |
| 570-2733 | Withdrawn | |
| 570-0705 | Withdrawn | |
| 570-2806 | Withdrawn | |
| 570-1458 | Withdrawn | |
| 570-2906 | Withdrawn | |
| 570-1875 | Withdrawn | |
| 570-2011 | Withdrawn | |
| 570-2463 | Withdrawn | |
| 570-2734 | Withdrawn | |
| 888-2518 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 95,039 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
Showing 12 of 367. All products under Orthopedic Tray
Recalls Naming This Product
3 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. | 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. | 48 units |
| Stradis Medical, LLC dba Stradis Healthcare | UDI-DI | 2022-02-25 | Class II | Process change control | The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit. | 348 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.