Vitalitec
QUICK RELEASE Micro Kerrison Rongeur, Rongeur, thin footplate, 12 mm bite open 40d UP, 1mm, 8" - for cervical use only
1manufacturer
78catalogue numbers in this listing
1510(k) clearance
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 | Vitalitec International Medizintechnik GmbH, Germany |
|---|---|
| FDA product code | HAE |
| Device type | Rongeur, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4840 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2023-06-28 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VK.J904QRBC90 | In distribution | |
| VK.J901QRS | In distribution | |
| VK.J1005QRBC | In distribution | |
| VK.J906QRBC | In distribution | |
| VK.J1002QRS | In distribution | |
| VK.J1003CVUQR | In distribution | |
| VMJ805QR | In distribution | |
| VK.J1103QR90 | In distribution | |
| VMJ1002QRBC | In distribution | |
| VK.J704CVUQR | In distribution | |
| VK.J702QR90D | In distribution | |
| VK.J1101CTS | In distribution | |
| VK.J1001QRBC | In distribution | |
| VMJ903QR | In distribution | |
| VK.J801CVUQR | In distribution | |
| VK.J1001QRS | In distribution | |
| VK.J805CVUQR | In distribution | |
| VK.J704QRS | In distribution | |
| VK.J705QRS | In distribution | |
| VK.J801QRF | In distribution | |
| VK.J9025QR | In distribution | |
| VMJ902QR | In distribution | |
| VK.J1105QR | In distribution | |
| VK.J902QRS | In distribution | |
| VK.J706CT90 | In distribution | |
| VK.J703CVUQR | In distribution | |
| VK.J702QRS | In distribution | |
| VK.J901QRBC90 | In distribution | |
| VMJ8025QR | In distribution | |
| VMJ904QR | In distribution | |
| VK.J1005CVUQR | In distribution | |
| VMJ1003QRS | In distribution | |
| VK.J902CTD | In distribution | |
| VMJ1002QRS | In distribution | |
| VK.J704CT90 | In distribution | |
| VK.J705CVUQR | In distribution | |
| VMJ1005QRS | In distribution | |
| VK.J806CT90 | In distribution | |
| VK.J1306QR | In distribution | |
| VK.J1004QRS | In distribution | |
| VK.J804QRF | In distribution | |
| VMJ704QR | In distribution | |
| VMJ804QR | In distribution | |
| VMJ701QR | In distribution | |
| VK.J703CVLQR | In distribution | |
| VK.J905QRBC90 | In distribution | |
| VMJ801QR | In distribution | |
| VK.J11025CT | In distribution | |
| VK.J903QRS | In distribution | |
| VK.J703QRS | In distribution | |
| VMJ901QR | In distribution | |
| VMJ1005QR | In distribution | |
| VK.J1006CTBC | In distribution | |
| VMJ703QR | In distribution | |
| VK.J1004QRBC | In distribution | |
| VMJ702QR | In distribution | |
| VK.J1001CVUQR | In distribution | |
| VMJ802QR | In distribution | |
| VK.J701CVUQR | In distribution | |
| VK.J1202QR | In distribution | |
| VMJ905QR | In distribution | |
| VK.J1305QR | In distribution | |
| VMJ803QR | In distribution | |
| VK.J7015QR90 | In distribution | |
| VK.J1001QRBC90 | In distribution | |
| VMJ1004QRS | In distribution | |
| VK.J1006QRS | In distribution | |
| VMJ1001QRS | In distribution | |
| VMJ8015QR | In distribution | |
| VK.J702CVUQR | In distribution | |
| VMJ705QR | In distribution | |
| VK.J902QRBC90 | In distribution | |
| VK.J1006QRBC | In distribution | |
| VK.J11035CT | In distribution | |
| VK.J801CT90 | In distribution | |
| VK.J901CTD | In distribution | |
| VK.J702QR40D | In distribution | |
| VK.J1005QRS | In distribution |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152734 | 2016-06-18 |
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.