GalaFLEX 3DR
GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Oval
1manufacturer
6catalogue 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 | Storage environment temperature 15 to 25 °C; Special storage condition: Do not use if the center of the temperature indicator is black. |
| Sizes | Length 15.5 to 21 cm; width 5.3 to 7.5 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FR3D06BD | Length 21 cm | 2 | In distribution |
| FR3D01BD | Length 15.5 cm | In distribution | |
| FR3D04BD | Width 6.4 cm | 2 | In distribution |
| FR3D03BD | Width 6.4 cm | In distribution | |
| FR3D02BD | Width 5.3 cm | 2 | In distribution |
| FR3D05BD | Width 7.5 cm | 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 3D | Davol Inc. | 7 |
| 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.