Stradis Healthcare
Custom Surgical KIT Endovenous Pack Stradis
1manufacturer
263catalogue 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 | OEZ |
| Device type | Cardiovascular Procedure Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Premarket notification | Exempt |
| Record published | 2022-03-15 |
| Record revised | 2022-06-17 (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, serial number |
| Packaging | Case of 5, case of 6, case of 20, pack of 5, case of 8, case of 3 |
| Sizes | Length 45 cm; catheter gauge 4 Fr |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 682-2502 | In distribution | |
| 682-625 | In distribution | |
| 682-1349 | In distribution | |
| 682-1886 | In distribution | |
| 682-2254R1 | In distribution | |
| 570-2911 | In distribution | |
| 682-1596 | In distribution | |
| 40759MMS | In distribution | |
| 682-1771 | In distribution | |
| 682-281R2 | In distribution | |
| 682-541 R1 | In distribution | |
| 525-037 | Length 45 cm | In distribution |
| 682-527 | In distribution | |
| 570-3210 | In distribution | |
| 682-1573R1 | In distribution | |
| 682-1230 R1 | In distribution | |
| 682-2263 | In distribution | |
| 682-130R1 | In distribution | |
| 570-2823 | In distribution | |
| 682-370 | In distribution | |
| 682-1864R1 | In distribution | |
| 617-018 | In distribution | |
| 570-1425 | In distribution | |
| 682-2143R1 | In distribution | |
| 682-2127 | In distribution | |
| 682-588 | In distribution | |
| 682-1632 | In distribution | |
| 682-431R1 | In distribution | |
| 682-1979R1 | In distribution | |
| 682-177R1 | In distribution | |
| 682-975R2 | In distribution | |
| 682-1540R1 | In distribution | |
| 682-2274 | In distribution | |
| 570-2920 | In distribution | |
| 570-2954 | In distribution | |
| 570-2689R1 | Withdrawn | |
| 570-2743 | Withdrawn | |
| 682-1953 | Withdrawn | |
| 682-1751 | Withdrawn | |
| 570-2822 | Withdrawn | |
| 682-340 R1 | Withdrawn | |
| 570-1056 | Withdrawn | |
| 682-2230 | Withdrawn | |
| 682-573 | Withdrawn | |
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Showing 250 of 263 catalogue numbers.
Same Product Code
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|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 40,731 |
| Medline Industries, Inc. | Medline Industries, Inc. | 17,468 |
| Avid TruCustom | Avid Medical, Inc. | 2,785 |
| Namic | Medline Industries, Inc. | 2,718 |
| Merit Medical® | Merit Medical Systems, Inc. | 2,399 |
| Halyard | Avid Medical, Inc. | 2,108 |
| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Regard™ | ROi CPS LLC | 192 |
| Stradis | Stradis Healthcare | 108 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 72 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 51 |
Showing 12 of 52. All products under Cardiovascular Procedure Kit
Recalls Naming This Product
11 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. | 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. | 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. | 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. | 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. | 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. | 40 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. | 400 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. | 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. | 105 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.