GalaFLEX 3d
GalaFLEX 3D Scaffold, 7.6 cm x 20.3 cm, Rectangle
1manufacturer
7catalogue 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 | Davol Inc., United States |
|---|---|
| FDA product code | OOD |
| Device type | Surgical Film |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| Record published | 2026-04-30 |
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: Do not use if the center of the temperature indicator is black.; Storage environment temperature 15 to 25 °C |
| Sizes | Width 5.3 to 7.6 cm; length 15.5 to 21 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SH3D01BD | Width 5.3 cm | In distribution | |
| SH3D04BD | Width 6.4 cm | 2 | In distribution |
| SH3D07BD | Width 7.6 cm | In distribution | |
| SH3D03BD | Length 18.5 cm | In distribution | |
| SH3D05BD | Width 7.5 cm | In distribution | |
| SH3D06BD | Length 21 cm | 2 | In distribution |
| SH3D02BD | Width 5.3 cm | 2 | In distribution |
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 3DR | Davol Inc. | 6 |
| GalaFLEX | Davol Inc. | 5 |
| Gelfilm | Pharmacia & Upjohn Company LLC | 2 |
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.