Aesculap
BALLENGER Swivel Knife, 8 1/4" (210 mm), bayonet-shaped, 5 x 4 mm
3manufacturers in China registered for this device type
13catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | KAS |
| Device type | Knife, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-22 |
| Record revised | 2021-06-23 (version 2) |
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 | 2021-05-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OL113R | In distribution | |
| OL112R | In distribution | |
| US140 | In distribution | |
| OL120R | In distribution | |
| OL102R | In distribution | |
| OL104R | In distribution | |
| OL355R | In distribution | |
| OL354R | In distribution | |
| OL111R | In distribution | |
| OL356R | In distribution | |
| OL114R | In distribution | |
| OL109R | In distribution | |
| OL107R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 21 |
| Ambler Surgical | Ambler Surgical, LLC | 18 |
| V. Mueller | Steris Corporation | 12 |
| Knife | KLS-Martin L.P. | 11 |
| 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.