Intrafix
INTRAFIX Tibial Sheath Inserter with Fixed Handle
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Svenson Network Holdings Limited | Hk | Hong Kong | Manufacturer | 7 |
Record
| Listed by | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | GEF |
| Device type | Applier, Staple, Surgical, |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-03-17 |
| Record revised | 2024-09-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 254616 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Applier, Staple, Surgical, | DePuy Mitek, Inc. | 4 |
| HI-Line | Aesculap AG | 3 |
| GII | DePuy Mitek, Inc. | 2 |
| Rigidfix | Medos International Sàrl | 1 |
| Applier, Staple, Surgical, | Zimmer, Inc. | 1 |
| Tacit | DePuy Mitek, Inc. | 1 |
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.