Phasix
Phasix ST Mesh with Echo 2 Positioning System, 30 cm x 35 cm (12" x 14"), Ellipse
1manufacturer
37catalogue 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 | 2015-04-13 |
| Record revised | 2025-08-18 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 30 °C |
| Sizes | Length 6 to 50 cm; width 8 to 50 cm; outer diameter 4.83 to 15 cm; height 3.56 to 3.81 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1190200 | Length 10.2 cm | In distribution |
| 1190011 | Outer Diameter 11 cm | In distribution |
| 1211823 | Length 18 cm | In distribution |
| 1190616 | Width 16 cm | In distribution |
| 1190400 | Length 20.3 cm | In distribution |
| 1191530 | Width 30 cm | In distribution |
| 1191010 | Width 10 cm | In distribution |
| 1200015 | Outer Diameter 15 cm | In distribution |
| 1191525 | Length 15 cm | In distribution |
| 1190808 | Length 8 cm | In distribution |
| 1190500 | Width 30.5 cm | In distribution |
| 1194545 | Length 45 cm | In distribution |
| 1191025 | Length 10 cm | In distribution |
| 1195050 | Length 50 cm | In distribution |
| 1190300 | Width 20.3 cm | In distribution |
| 1192040 | Length 20 cm | In distribution |
| 1193030 | Length 30 cm | In distribution |
| 1190820 | Width 20 cm | In distribution |
| 1221530 | Width 30 cm | In distribution |
| 1213035 | Width 35 cm | In distribution |
| 1193045 | Width 45 cm | In distribution |
| 1221520 | Length 15 cm | In distribution |
| 1192020 | Length 20 cm | In distribution |
| 1194040 | Width 40 cm | In distribution |
| 1203035 | Width 35 cm | In distribution |
| 1211525 | Width 25 cm | In distribution |
| 1190100 | Outer Diameter 7.6 cm | In distribution |
| 1190816 | Width 16 cm | In distribution |
| 1212533 | Width 33 cm | In distribution |
| 1192540 | Width 40 cm | In distribution |
| 1191020 | Width 20 cm | In distribution |
| 1190602 | Outer Diameter 4.83 cm | In distribution |
| 1190603 | Height 3.56 cm | In distribution |
| 1192030 | Width 30 cm | In distribution |
| 1220812 | Width 12 cm | In distribution |
| 1220011 | Outer Diameter 11 cm | In distribution |
| 1193535 | Width 35 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.