Jedmed
Handle Only Rotating Shaft Rongeurs
3manufacturers in China registered for this device type
17catalogue 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 | Jedmed Instrument Company, United States |
|---|---|
| FDA product code | KBB |
| Device type | Rongeur, Nasal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 51-0515 | In distribution | |
| 51-0860 | In distribution | |
| 51-0883 | In distribution | |
| 51-1951 | In distribution | |
| 51-0873 | In distribution | |
| 51-1425 | In distribution | |
| 51-1460 | In distribution | |
| 51-1952 | In distribution | |
| 51-0508 | In distribution | |
| 51-1461 | In distribution | |
| 51-0510 | In distribution | |
| 51-1953 | In distribution | |
| 51-0872 | In distribution | |
| 51-1450 | In distribution | |
| 51-0882 | In distribution | |
| 51-3106 | In distribution | |
| 51-1950 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tri-D Kerrison Rongeur | Mizuho Corporation | 20 |
| 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 |
| 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.