Stradis
Cardiovascular/Vein Procedure Kit 682-1959 McCormick Vein Basic Procedure Pack, Package of 5 with M75268219590 DI individual packages of 682-1959 McCormick Vein Basic Procedure Pack…
Cardiovascular/Vein Procedure Kit 682-1959 McCormick Vein Basic Procedure Pack, Package of 5 with M75268219590 DI individual packages of 682-1959 McCormick Vein Basic Procedure Pack individuals.
1manufacturer
108catalogue 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 | 2022-03-17 |
| Record revised | 2022-06-17 (version 8) |
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 | Pack of 5, case of 5, pack of 4, pack of 20 |
| Distribution end date | 2023-02-07 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 682-491R1 | 5 | In distribution | |
| 682-1368 | In distribution | ||
| 682-1760 | In distribution | ||
| 682-177 | In distribution | ||
| 682-1993R1 | 5 | In distribution | |
| 682-1993R1 | In distribution | ||
| 682-1368R1 | 5 | In distribution | |
| 682-1738 | In distribution | ||
| 682-484R1 | 5 | In distribution | |
| 570-2953 | In distribution | ||
| 682-1963R1 | 5 | In distribution | |
| 682-484R1 | In distribution | ||
| 609-049 | In distribution | ||
| 682-2143 | In distribution | ||
| 682-1290 | Withdrawn | ||
| 682-2219 | Withdrawn | ||
| 682-2267 | Withdrawn | ||
| 682-1732 | Withdrawn | ||
| 682-1735 R1 | Withdrawn | ||
| 682-1386 | Withdrawn | ||
| 682-263 | Withdrawn | ||
| 682-1598 | Withdrawn | ||
| 682-1242 | Withdrawn | ||
| 682-373 | Withdrawn | ||
| 682-1946 | Withdrawn | ||
| 682-1989 | Withdrawn | ||
| 682-1230 | Withdrawn | ||
| 682-1368R1 | Withdrawn | ||
| 682-277R1 | Withdrawn | ||
| 682-1264 | Withdrawn | ||
| 682-1517 | Withdrawn | ||
| 682-1496 | Withdrawn | ||
| SS79878 | Withdrawn | ||
| 686-108R1 | Withdrawn | ||
| 682-264 | Withdrawn | ||
| 682-1568 | Withdrawn | ||
| 682-1752 R3 | Withdrawn | ||
| 682-2267 | Withdrawn | ||
| 682-757 | Withdrawn | ||
| 682-589 | Withdrawn | ||
| 682-2502 | Withdrawn | ||
| 682-2282 | Withdrawn | ||
| 682-961 | Withdrawn | ||
| 682-827 | Withdrawn | ||
| 682-917 | Withdrawn | ||
| 682-1230 | Withdrawn | ||
| 682-1307 | Withdrawn | ||
| 682-281R1 | Withdrawn | ||
| 682-1348 | Withdrawn | ||
| 682-353 | Withdrawn | ||
| 570-3119 | Withdrawn | ||
| 682-1886 | Withdrawn | ||
| 617-018 | Withdrawn | ||
| 682-1596 | Withdrawn | ||
| 682-2360 | Withdrawn | ||
| 682-1498 | Withdrawn | ||
| 682-416 | Withdrawn | ||
| 682-151 | Withdrawn | ||
| 682-1473 | Withdrawn | ||
| 682-494 | Withdrawn | ||
| 682-2337 | Withdrawn | ||
| 682-527 | Withdrawn | ||
| 682-400R1 | Withdrawn | ||
| 682-1962 | Withdrawn | ||
| 682-960 | Withdrawn | ||
| 682-321 | Withdrawn | ||
| 682-919 | Withdrawn | ||
| 682-1349 | Withdrawn | ||
| 682-2212 | Withdrawn | ||
| 682-1341 | Withdrawn | ||
| 682-320 | Withdrawn | ||
| 682-1501 | Withdrawn | ||
| 682-1269 | Withdrawn | ||
| 682-491R1 | Withdrawn | ||
| 682-2316R1 | Withdrawn | ||
| 682-970 | Withdrawn | ||
| 682-277 | Withdrawn | ||
| 682-218 | Withdrawn | ||
| 682-513 | Withdrawn | ||
| 682-1700 | Withdrawn | ||
| 682-755 | Withdrawn | ||
| 686-100R1 | Withdrawn | ||
| 682-193R1 | Withdrawn | ||
| 525-037 | Withdrawn | ||
| 682-832 | Withdrawn | ||
| 682-351R1 | Withdrawn | ||
| 682-030 | Withdrawn | ||
| 682-177 | Withdrawn | ||
| 682-026 | Withdrawn | ||
| 682-330 | Withdrawn | ||
| 682-1959 | Withdrawn | ||
| 682-606 | Withdrawn | ||
| 682-1291 R1 | Withdrawn | ||
| 682-2352 | Withdrawn | ||
| 682-1752 R4 | Withdrawn | ||
| 682-286 | Withdrawn | ||
| 682-1516 | Withdrawn | ||
| 682-1691 R1 | Withdrawn | ||
| 682-1681 | Withdrawn | ||
| 682-584 | Withdrawn | ||
| 682-218 | Withdrawn | ||
| 682-1264 | Withdrawn | ||
| 682-947 | Withdrawn | ||
| 682-1963R1 | Withdrawn | ||
| 682-130 | Withdrawn | ||
| 682-1735 | Withdrawn | ||
| 682-257 | Withdrawn | ||
| 682-1963 | Withdrawn |
Same Product Code
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| ACS | American Contract Systems, Inc. | 1,540 |
| Medline | Medline Industries, Inc. | 428 |
| Stradis Healthcare | Stradis Healthcare | 263 |
| Regard™ | ROi CPS LLC | 192 |
| 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
6 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. | 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. | 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. | 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. | 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.