Bausch + Lomb
Rongeur Morgenstein-Kerrison
3manufacturers in China registered for this device type
7catalogue 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 | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | KBB |
| Device type | Rongeur, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-07-30 |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N1950 | In distribution | |
| N1951 | In distribution | |
| N1940 | In distribution | |
| N1952 | In distribution | |
| N3380 | In distribution | |
| N1451 | In distribution | |
| N3106 | 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 |
| Rongeur, Nasal | Biomet Microfixation | 11 |
| 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 |
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.