Integra® Miltex®
Integra® Miltex® Ruskin Rongeur 5-7/8", Curved, 3mm Bite, Double Action
2manufacturers in China registered for this device type
24catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JZA |
| Device type | Rongeur, Mastoid |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-12-21 |
| Record revised | 2023-04-28 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19-1232 | In distribution | |
| 19-856 | In distribution | |
| 18-1994 | In distribution | |
| 18-1992 | In distribution | |
| MH19-1232 | In distribution | |
| MH19-848 | In distribution | |
| 19-840 | In distribution | |
| MH19-850 | In distribution | |
| 19-844 | In distribution | |
| 19-1234 | In distribution | |
| 19-849 | In distribution | |
| 19-848 | In distribution | |
| 19-1230 | In distribution | |
| 19-854 | In distribution | |
| 18-1996 | In distribution | |
| MH19-852 | In distribution | |
| 19-850 | In distribution | |
| MH19-844 | In distribution | |
| 18-1990 | In distribution | |
| 19-852 | In distribution | |
| 19-808 | In distribution | |
| MH19-1230 | In distribution | |
| MH19-849 | In distribution | |
| 19-804 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rongeur | KLS-Martin L.P. | 7 |
| 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.