Integra®
Integra® Ruskin Rongeur ,Double Action, Curved,5 mm
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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KBB |
| Device type | Rongeur, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2023-04-18 (version 5) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3712211 | In distribution | |
| 3712008 | In distribution | |
| 3712003 | In distribution | |
| 3712009 | In distribution | |
| 3712026 | In distribution | |
| 3712200 | In distribution | |
| 3712212 | In distribution | |
| 3712002 | In distribution | |
| 3712027 | In distribution | |
| 3712201 | In distribution | |
| 3712219 | 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 |
| 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.