Rongeur
Cutting, Antrum, Kerrison, Angled UP, 5 X 5 MM Jaws
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (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 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | JZA |
| Device type | Rongeur, Mastoid |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2021-04-21 (version 6) |
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 | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37-389-02-07 | In distribution | |
| 37-389-01-07 | In distribution | |
| 36-463-19-07 | 19 CM | In distribution |
| 37-389-00-07 | In distribution | |
| 37-389-03-07 | In distribution | |
| 36-460-17-07 | 17 CM | Withdrawn |
| 36-461-17-07 | 17 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 24 |
| Integra® | Integra LifeSciences Production Corporation | 5 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 4 |
| Millennium | Avalign Technologies, Inc. | 3 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 1 |
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.