Knife
Swivel, Ballenger, Bayonet, 4 MM Blade
3manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (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 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | KAS |
| Device type | Knife, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2024-08-27 (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 | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37-444-16-07 | 15.5 CM | In distribution |
| 37-504-04-07 | 21 CM | In distribution |
| 37-505-04-07 | 20.5 CM | In distribution |
| 37-495-01-07 | 18 CM | In distribution |
| 37-505-03-07 | 20.5 CM | In distribution |
| 37-441-01-07 | 15 CM | In distribution |
| 37-440-01-07 | 15 CM | In distribution |
| 37-495-02-07 | 18 CM | In distribution |
| 37-504-03-07 | 21 CM | In distribution |
| 37-505-05-07 | 20.5 CM | In distribution |
| 37-504-05-07 | 21 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 21 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| Aesculap | Aesculap AG | 13 |
| V. Mueller | Steris Corporation | 12 |
| Van Sickle | VAN Sickle Surgical Instruments, Inc. | 10 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 10 |
| MicroFrance® | Integra Microfrance SAS | 9 |
| Avalign | Avalign Technologies, Inc. | 8 |
| Pilling | Teleflex Medical LLC | 8 |
| Knife, Nasal | Black & Black Surgical, Inc. | 6 |
| Ballenger Swivel Knife | Sontec Instruments, Inc. | 5 |
| Integra® | Integra LifeSciences Production Corporation | 5 |
Showing 12 of 32. All products under Knife, Nasal
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.