Rongeur, Nasal
11 catalogue numbers from 09-0174, listed by Biomet Microfixation, United States, under Rongeur, Nasal. 3 manufacturers in China are registered for this product code.
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). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Biomet Microfixation, United States |
|---|---|
| FDA product code | KBB |
| Device type | Rongeur, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-22 |
| Record revised | 2025-05-30 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09-0174 | In distribution | |
| 03-0087 | In distribution | |
| 03-1700 | In distribution | |
| 07-0038 | In distribution | |
| 33-3105 | In distribution | |
| 07-0039 | In distribution | |
| 03-0086 | In distribution | |
| 02-0068 | In distribution | |
| 02-0070 | In distribution | |
| 02-0069 | In distribution | |
| 09-0177 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-D Kerrison Rongeur | Mizuho Corporation | 20 |
| Jedmed | Jedmed Instrument Company | 17 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 17 |
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 13 |
| Integra® | Integra LifeSciences Production Corporation | 11 |
| Kerrison rongeur | Mizuho Corporation | 10 |
| Millennium | Avalign Technologies, Inc. | 9 |
| Marina Medical | Marina Medical Instruments, Inc. | 9 |
| Avalign | Avalign Technologies, Inc. | 9 |
| Rongeur | KLS-Martin L.P. | 9 |
| Inka | The Trustee for Kaiser Family Trust | 8 |
Showing 12 of 33. All products under Rongeur, 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.