Integra® Miltex®
Integra® Miltex® Miltex-Kerrison Rongeur 7" 5mm 40 degree forward angle, improved handle
1manufacturer
25catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. 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 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HAE |
| Device type | Rongeur, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4840 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K092227 |
| Record published | 2017-05-22 |
| Record revised | 2024-10-11 (version 11) |
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 |
| Sizes | Length 8 in; width 3 mm; angle 90 ° |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MH26-397 | In distribution | |
| 26-393 | In distribution | |
| 26-392B | In distribution | |
| 26-390 | In distribution | |
| 26326 | In distribution | |
| 26-339B | In distribution | |
| 26330 | In distribution | |
| 26-393A | In distribution | |
| 26-339A | In distribution | |
| 26-388 | In distribution | |
| 26-340 | In distribution | |
| MH26-336 | In distribution | |
| 26-335 | In distribution | |
| 26-331 | In distribution | |
| 26-337 | In distribution | |
| 26-393B | In distribution | |
| 26-389 | In distribution | |
| 26-338 | Length 8 in | In distribution |
| 26-392A | In distribution | |
| 26-336 | In distribution | |
| 26-392 | In distribution | |
| 26-332 | In distribution | |
| 26-328 | Withdrawn | |
| 26-327 | Withdrawn | |
| MH26-339A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 1,397 |
| GEN2 | Surgix Medical LLC | 1,350 |
| Boss Instruments | Boss Instruments, Ltd. | 1,086 |
| Avalign | Avalign Technologies, Inc. | 881 |
| Ambler Surgical | Ambler Surgical, LLC | 723 |
| V. Mueller | Steris Corporation | 685 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 476 |
| Rongeur, Manual | Fehling Instruments GmbH | 383 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 365 |
| Wiggins Medical | Ebner Medical LLC | 343 |
| Punch | KLS-Martin L.P. | 333 |
| Stealth Surgical | Boss Instruments, Ltd. | 242 |
Showing 12 of 158. All products under Rongeur, Manual
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.