Stradis Healthcare
Custom Surgical KIT Plastic & Cosmetic Surgery Pack
2manufacturers in China registered for this device type
81catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | FTN |
| Device type | Plastic Surgery And Accessories Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3925 |
| Premarket notification | Exempt |
| Record published | 2022-03-07 |
| Record revised | 2023-01-09 (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 5, case of 4, case of 3, pack of 4, case of 6, pack of 5 |
| Distribution end date | 2023-02-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 693-166 | In distribution | |
| 570-3234 | In distribution | |
| 570-2952 | In distribution | |
| 693-003 | In distribution | |
| 681-298 | In distribution | |
| 570-2885 | In distribution | |
| 570-2959 | In distribution | |
| 570-2909 | In distribution | |
| 682-1228 | In distribution | |
| 681-001 | In distribution | |
| 681-505 | In distribution | |
| 570-3226 | In distribution | |
| 681-287 | In distribution | |
| 570-3228 | In distribution | |
| 693-276 | In distribution | |
| 570-2826 | In distribution | |
| 681-228 | In distribution | |
| 570-3227 | In distribution | |
| 570-3193 | In distribution | |
| 681-275 R3 | In distribution | |
| 682-1994 | Withdrawn | |
| 888-2550 | Withdrawn | |
| 570-2919 | Withdrawn | |
| 570-2398 | Withdrawn | |
| 681-292 | Withdrawn | |
| 681-295 | Withdrawn | |
| 682-419R1 | Withdrawn | |
| 570-2727 | Withdrawn | |
| 682-1936 | Withdrawn | |
| 693-265 | Withdrawn | |
| 681-299 | Withdrawn | |
| 696-010 | Withdrawn | |
| 570-3229 | Withdrawn | |
| 570-2875 | Withdrawn | |
| 681-346 | Withdrawn | |
| 570-2723 | Withdrawn | |
| 693-167 | Withdrawn | |
| 609-009 | Withdrawn | |
| 570-2798 | Withdrawn | |
| 682-1545 R1 | Withdrawn | |
| 570-2895 | Withdrawn | |
| 570-2741 | Withdrawn | |
| 681-345 | Withdrawn | |
| 570-2556 | Withdrawn | |
| 682-2325 | Withdrawn | |
| 888-2618 | Withdrawn | |
| 570-2881 | Withdrawn | |
| 696-010R1 | Withdrawn | |
| 693-268 | Withdrawn | |
| 681-254 | Withdrawn | |
| 682-334R1 | Withdrawn | |
| 570-2400 | Withdrawn | |
| 693-189 | Withdrawn | |
| 570-2881 | Withdrawn | |
| 570-2825 | Withdrawn | |
| 681-227 | Withdrawn | |
| 570-2399 | Withdrawn | |
| 696-010 | Withdrawn | |
| 570-2397 | Withdrawn | |
| 570-2797 | Withdrawn | |
| 655-090 | Withdrawn | |
| 681-500R1 | Withdrawn | |
| 681-343 | Withdrawn | |
| 681-502 | Withdrawn | |
| 681-300 | Withdrawn | |
| 570-1476 | Withdrawn | |
| 570-0621 | Withdrawn | |
| 681-333 | Withdrawn | |
| 681-300 | Withdrawn | |
| 570-1457 | Withdrawn | |
| 570-2726 | Withdrawn | |
| 570-0611 | Withdrawn | |
| 693-276 | Withdrawn | |
| 682-833 | Withdrawn | |
| 570-2724 | Withdrawn | |
| 681-506 R1 | Withdrawn | |
| 681-248 | Withdrawn | |
| 570-1517 | Withdrawn | |
| 681-291 | Withdrawn | |
| 681-288 | Withdrawn | |
| 693-118 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 4,366 |
| ACS | American Contract Systems, Inc. | 109 |
| Stradis | Stradis Healthcare | 102 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 20 |
| Regard™ | ROi CPS LLC | 13 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 12 |
| Medline | Medline Industries, Inc. | 5 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 5 |
| Stradis Medical, LLC. | Stradis Healthcare | 5 |
| Invenio | GRI-Alleset, Inc. | 3 |
| Bausch and Lomb | Medline Industries, Inc. | 3 |
Showing 12 of 19. All products under Plastic Surgery And Accessories Kit
Recalls Naming This Product
5 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. | 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. | 8 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. | 6 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. | 16 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.