GalaFLEX Lite
GalaFlex LITE Scaffold, 25.0 cm x 30.0 cm, Rectangle
1manufacturer
13catalogue 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 | 2025-09-25 |
| Record revised | 2025-10-30 (version 2) |
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 7.6 to 30 cm; width 2.5 to 25 cm; outer diameter 13 to 25 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GFLT0019BD | Outer Diameter 19 cm | In distribution |
| GFLT0520BD | Length 20 cm | In distribution |
| GFLT0017BD | Outer Diameter 17 cm | In distribution |
| GFLT2530BD | Width 25 cm | In distribution |
| GFLT1020BD | Length 20 cm | In distribution |
| GFLT2025BD | Width 20 cm | In distribution |
| GFLT0015BD | Outer Diameter 15 cm | In distribution |
| GFLT0013BD | Outer Diameter 13 cm | In distribution |
| GFLT0022BD | Outer Diameter 22 cm | In distribution |
| GFLT1520BD | Length 20 cm | In distribution |
| GFLT0025BD | Outer Diameter 25 cm | In distribution |
| GFLT0207BD | Width 2.5 cm | In distribution |
| GFLT0515BD | Width 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 3DR | Tepha, Incorporated | 13 |
| GalaFORM 3D | Tepha, Incorporated | 13 |
| GalaFLEX 3D | Davol Inc. | 7 |
| 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.