Henry Schein
Pack Major Plastic F/ Advanced Cosmetic Surgery Center
2manufacturers in China registered for this device type
93catalogue 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 | Henry Schein, Inc., 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 | 2023-07-30 |
| Record revised | 2022-06-17 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5702915 | 15 | In distribution | |
| 5701551 | 3 | In distribution | |
| 5703147 | 4 | In distribution | |
| 5703224 | 4 | In distribution | |
| 5701913 | 6 | In distribution | |
| 5703070 | 2 | In distribution | |
| 5702802 | 10 | In distribution | |
| 5703119 | 6 | In distribution | |
| 5702820 | 2 | In distribution | |
| 5702875 | 10 | In distribution | |
| 5703064 | 6 | In distribution | |
| 5703234 | 2 | In distribution | |
| 5702881 | 5 | In distribution | |
| 5703234 | 8 | In distribution | |
| 5702885 | 8 | In distribution | |
| 5703877 | 4 | In distribution | |
| 5702919 | 5 | In distribution | |
| 5702723 | 8 | In distribution | |
| 5702669 | 12 | In distribution | |
| 5702959 | 3 | In distribution | |
| 5701692 | 3 | In distribution | |
| 8882586 | In distribution | ||
| 5702742 | 2 | In distribution | |
| 5702398 | 5 | In distribution | |
| 5703093 | 4 | In distribution | |
| 5702273 | 3 | In distribution | |
| 5701168 | In distribution | ||
| 5703193 | 4 | In distribution | |
| 5703228 | 3 | In distribution | |
| 5701915 | 5 | In distribution | |
| 5702952 | 2 | In distribution | |
| 5702214 | 3 | In distribution | |
| 5700737 | 50 | In distribution | |
| 5701550 | 5 | In distribution | |
| 5703119 | 2 | In distribution | |
| 5700611 | 4 | In distribution | |
| 5703226 | 3 | In distribution | |
| 5703225 | 4 | In distribution | |
| 5700621 | In distribution | ||
| 5701517 | 5 | In distribution | |
| 5703117 | 4 | In distribution | |
| 5701110 | In distribution | ||
| 8882608 | In distribution | ||
| 8882638 | In distribution | ||
| 5702724 | 2 | In distribution | |
| 5703118 | 4 | In distribution | |
| 5700611 | In distribution | ||
| 8882603 | In distribution | ||
| 5703151 | 3 | In distribution | |
| 5702727 | 2 | In distribution | |
| 5702723 | 2 | In distribution | |
| 5700599 | In distribution | ||
| 8882602 | In distribution | ||
| 5704245 | 10 | In distribution | |
| 5702898 | 6 | In distribution | |
| 5703228 | 4 | In distribution | |
| 5703118 | 6 | In distribution | |
| 5703150 | 3 | In distribution | |
| 5702719 | 4 | In distribution | |
| 5702718 | 12 | In distribution | |
| 5702899 | 8 | In distribution | |
| 5703229 | 4 | In distribution | |
| 5702895 | 8 | In distribution | |
| 5702726 | 2 | In distribution | |
| 5701911 | 4 | In distribution | |
| 5701411 | In distribution | ||
| 5701914 | 2 | In distribution | |
| 5702935 | 10 | In distribution | |
| 5702726 | 2 | In distribution | |
| 5702741 | 9 | In distribution | |
| 5702399 | 2 | In distribution | |
| 5703193 | 5 | In distribution | |
| 5702959 | 3 | In distribution | |
| 5703229 | 5 | In distribution | |
| 5703227 | 3 | In distribution | |
| 5703093 | 7 | In distribution | |
| 5703224 | 3 | In distribution | |
| 5703150 | 5 | In distribution | |
| 5703149 | 3 | In distribution | |
| 8882427 | In distribution | ||
| 5703225 | 4 | In distribution | |
| 5701912 | 4 | In distribution | |
| 5703226 | 4 | In distribution | |
| 5703151 | 4 | In distribution | |
| 5703148 | 4 | In distribution | |
| 5702400 | 2 | In distribution | |
| 8882599 | In distribution | ||
| 8882617 | In distribution | ||
| 5702944 | 4 | In distribution | |
| 5703227 | 3 | In distribution | |
| 8882623 | In distribution | ||
| 5700613 | In distribution | ||
| 5703064 | 10 | In distribution |
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 |
| Stradis Healthcare | Stradis Healthcare | 81 |
| 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
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. | 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. | 328 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. | 42 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.