Gelfilm
Anti-adhesion dressing, bioabsorbable
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xiamen MK Health Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 7 |
Record
| Listed by | Pharmacia & Upjohn Company LLC, United States |
|---|---|
| FDA product code | OOD |
| Device type | Surgical Film |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-10-22 |
| Record revised | 2022-12-20 (version 7) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: See USP Controlled Room Temperature; Storage environment temperature 15 to 30 °C |
| Sizes | Width 100 mm; length 125 mm |
| Distribution end date | 2016-05-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Gelfilm® Sterile Film Sterile film 1’s (125 sq cm) | Length 125 mm | In distribution |
| Gelfilm® Sterile Film Sterile film 1’s (125 sq cm) | Width 100 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Phasix | Davol Inc. | 37 |
| GalaFLEX Scaffold | Tepha, Incorporated | 14 |
| GalaFLEX Lite | Tepha, Incorporated | 14 |
| GalaFLEX 3D | Tepha, Incorporated | 14 |
| GalaSHAPE 3D | Tepha, Incorporated | 14 |
| GalaFLEX Lite | Davol Inc. | 13 |
| GalaFLEX 3DR | Tepha, Incorporated | 13 |
| GalaFORM 3D | Tepha, Incorporated | 13 |
| GalaFLEX 3D | Davol Inc. | 7 |
| GalaFLEX 3DR | Davol Inc. | 6 |
| GalaFLEX | Davol Inc. | 5 |
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.