MAI
Catalogue number 81446, listed by Medical Action Industries, Inc., United States, under Plastic Surgery And Accessories Kit. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Medical Action Industries, 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 | 2020-11-05 |
| Record revised | 2022-06-17 (version 2) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE AT ROOM TEMPERATURE |
| Packaging | Pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81446 | 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 |
| Henry Schein | Henry Schein, Inc. | 93 |
| 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 |
Showing 12 of 19. All products under Plastic Surgery And Accessories Kit
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.