Tacit
TACIT Inserter 2.0mm
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 | 2015-09-01 |
| 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 | 2021-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 219620 | Withdrawn |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 |
| Intrafix | 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.