Provox FenestrationPunch
The Fenestration Punch is used for making small fenestrations in a Provox LaryTube at desired locations.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Atos Medical AB, Sweden |
|---|---|
| FDA product code | KTF |
| Device type | Punch, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-25 |
| Record revised | 2024-07-19 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 42 °C; Storage environment temperature 36 to 108 °F; Special storage condition: Keep dry. Keep away from sunlight |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7654 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 31 |
| V. Mueller | Steris Corporation | 25 |
| Boss Instruments | Boss Instruments, Ltd. | 22 |
| Millennium | Avalign Technologies, Inc. | 20 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 14 |
| Aesculap | Aesculap AG | 8 |
| Pilling | Teleflex Medical LLC | 7 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 6 |
| Avalign | Avalign Technologies, Inc. | 5 |
| Antrum Punch Rongeur | Sontec Instruments, Inc. | 5 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 5 |
| Punch Rongeur | Sontec Instruments, Inc. | 4 |
Showing 12 of 31. All products under Punch, Ent
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.