Ostrum Antrum Punch Rongeur
Ostrum Antrum Punch Rongeur Pediatric Back Bite Straight Shaft
2manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | KTF |
| Device type | Punch, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2018-09-11 |
| Record revised | 2024-03-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 5 to 5.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 468-300 | Length 5 in | In distribution |
| 468-316 | 2 x 7 Millimeter Bite | In distribution |
| 468-305 | 1.5 x 8 Millimeter Tip | In distribution |
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.