Quick Release
QUICK RELEASE Micro Kerrison Rongeur, thin footplate, 12 mm bite opening, 40d UP,1,5 mm, 8" -for cervical use only
1manufacturer
218catalogue 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 | 2016-11-28 |
| Record revised | 2018-03-29 (version 2) |
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.J803CVU | In distribution | |
| VK.J1002CVUQR | In distribution | |
| VK.J805QR90 | In distribution | |
| VK.J802CT90D | In distribution | |
| VK.J1101QRS | In distribution | |
| VK.J1102CT | In distribution | |
| VK.J803CTBC | In distribution | |
| VK.J704CTS | In distribution | |
| VK.J803CT90D | In distribution | |
| VK.J802QR | In distribution | |
| VK.J1102CTBD | In distribution | |
| VK.J806CT | In distribution | |
| VK.J1104CT | In distribution | |
| VK.J1003QR | In distribution | |
| VK.J7015CT | In distribution | |
| VK.J809CT | In distribution | |
| VK.J1001CTBC | In distribution | |
| VK.J1005CTBC | In distribution | |
| VK.J801CTBD90 | In distribution | |
| VK.J802CTS | In distribution | |
| VK.J1102CTB | In distribution | |
| VK.J1102CTBC | In distribution | |
| VK.J1102QRS | In distribution | |
| VK.J1102CTS | In distribution | |
| VK.J803QR90D | In distribution | |
| VK.J1105CTB | In distribution | |
| VK.J902CTBC | In distribution | |
| VK.J1104CTB | In distribution | |
| VK.J802CVLQR | In distribution | |
| VK.J801CT | In distribution | |
| VK.J903QR | In distribution | |
| VK.J1002CT | In distribution | |
| VK.J705QR | In distribution | |
| VK.J9015CT | In distribution | |
| VK.J801CTBC | In distribution | |
| VK.J8025CT | In distribution | |
| VK.J1004CT | In distribution | |
| VK.J1304CT | In distribution | |
| VK.J805CTBC | In distribution | |
| VK.J702QR90 | In distribution | |
| VK.J903CTBD | In distribution | |
| VK.J801CTBD | In distribution | |
| VK.J1103CT90 | In distribution | |
| VK.J1105CTBC | In distribution | |
| VK.J1106CT | In distribution | |
| VK.J1105CT90 | In distribution | |
| VK.J804QR90 | In distribution | |
| VK.J904QR | In distribution | |
| VK.J7015QR | In distribution | |
| VK.J1104CTBC | In distribution | |
| VK.J802CTSC | In distribution | |
| VK.J11045CTS | In distribution | |
| VK.J1003CTSC | In distribution | |
| VK.J1002CTSC | In distribution | |
| VK.J803QR | In distribution | |
| VK.J1306CT | In distribution | |
| VK.J906CTBC | In distribution | |
| VK.J801QRM | In distribution | |
| VK.J1004CVUQR | In distribution | |
| VK.J1101CT | In distribution | |
| VK.J703CTSC90 | In distribution | |
| VK.J802CTBC | In distribution | |
| VK.J702QR | In distribution | |
| VK.J8015CT | In distribution | |
| VK.J904QRBC | In distribution | |
| VK.J901CTS | In distribution | |
| VK.J805CT | In distribution | |
| VK.J803CTBD | In distribution | |
| VK.J1003CT | In distribution | |
| VK.J705CT | In distribution | |
| VK.J905CTBC | In distribution | |
| VK.J804CTBC | In distribution | |
| VK.J1103CTBD | In distribution | |
| VK.J906CTBD | In distribution | |
| VK.J802QR90 | In distribution | |
| VK.J803CTBD90 | In distribution | |
| VK.J802CVRQR | In distribution | |
| VK.J1301CT | In distribution | |
| VK.J703QR | In distribution | |
| VK.J703QR90 | In distribution | |
| VK.J902QR | In distribution | |
| VK.J801CTS | In distribution | |
| VK.J804CVU | In distribution | |
| VK.J802CT | In distribution | |
| VK.J902CTS | In distribution | |
| VK.J1101CTBD | In distribution | |
| VK.J902CT | In distribution | |
| VK.J702CTSC | In distribution | |
| VK.J1305CT | In distribution | |
| VK.J1004QR | In distribution | |
| VK.J804CTS | In distribution | |
| VK.J706CT | In distribution | |
| VK.J905CTBD | In distribution | |
| VK.J906CT | In distribution | |
| VK.J701QR | In distribution | |
| VK.805RHE | In distribution | |
| VK.J803QR40D | In distribution | |
| VK.J701QR90 | In distribution | |
| VK.J901QR | In distribution | |
| VK.J703CVRQR | In distribution | |
| VK.J904CT | In distribution | |
| VK.J1004CTSC | In distribution | |
| VK.J9015QR | In distribution | |
| VK.J801QR90D | In distribution | |
| VK.J1005CTSC | In distribution | |
| VK.J902CTBD | In distribution | |
| VK.J804CVRQR | In distribution | |
| VK.J802CTBD | In distribution | |
| VK.J1101CTBC | In distribution | |
| VK.J905QR | In distribution | |
| VK.J803QRF | In distribution | |
| VK.J703CT | In distribution | |
| VK.J1103CTBC | In distribution | |
| VK.802RHE | In distribution | |
| VK.J703CT90 | In distribution | |
| VK.J1103CTS | In distribution | |
| VK.J803CT90 | In distribution | |
| VK.J1003CTBC | In distribution | |
| VK.J803QR90 | In distribution | |
| VK.J1102QR | In distribution | |
| VK.J1106CT90 | In distribution | |
| VK.J802CVR | In distribution | |
| VK.J805QR | In distribution | |
| VK.J1105CTBD | In distribution | |
| VK.J805QRS | In distribution | |
| VK.J802QR90D | In distribution | |
| VK.J1203CT | In distribution | |
| VK.J805QR40D | In distribution | |
| VK.SJ902QR | In distribution | |
| VK.J1005QR | In distribution | |
| VK.J706QR | In distribution | |
| VK.J905QRBC | In distribution | |
| VK.J804QRS | In distribution | |
| VK.J801QR40D | In distribution | |
| VK.J903CTS | In distribution | |
| VK.J802CT90 | In distribution | |
| VK.J8015QR | In distribution | |
| VK.J901CTBD | In distribution | |
| VK.J805QR90D | In distribution | |
| VK.J803CVL | In distribution | |
| VK.J11025CTS | In distribution | |
| VK.J7025QR | In distribution | |
| VK.J901CTBC | In distribution | |
| VK.J704QR40D | In distribution | |
| VK.J702CTS | In distribution | |
| VK.J806CTBC | In distribution | |
| VK.J1103CTB | In distribution | |
| VK.J705QR40D | In distribution | |
| VK.J805CTS | In distribution | |
| VK.J1302CT | In distribution | |
| VK.J804QR90D | In distribution | |
| VK.J1001QR | In distribution | |
| VK.J8025QR | In distribution | |
| VK.J1101CTB | In distribution | |
| VK.J904CTBC | In distribution | |
| VK.J806QR | In distribution | |
| VK.J804QR | In distribution | |
| VK.J802QR40D | In distribution | |
| VK.J903CTBC | In distribution | |
| VK.J705CTS | In distribution | |
| VK.J702CT | In distribution | |
| VK.J804QR40D | In distribution | |
| VK.J1005CT | In distribution | |
| VK.J8015QRF | In distribution | |
| VK.J802QRS | In distribution | |
| VK.J802CVL | In distribution | |
| VK.J1103QRS | In distribution | |
| VK.J1004CTBC | In distribution | |
| VK.J704QR | In distribution | |
| VK.J701CT | In distribution | |
| VK.J803CVLQR | In distribution | |
| VK.J801QR90 | In distribution | |
| VK.J801CVLQR | In distribution | |
| VK.J806QRS | In distribution | |
| VK.J806QR90 | In distribution | |
| VK.J803CVUQR | In distribution | |
| VK.J902QRBC | In distribution | |
| VK.J1001CT | In distribution | |
| VK.J703CTS | In distribution | |
| VK.J806CTS | In distribution | |
| VK.J1105CT | In distribution | |
| VK.J1104CTBD | In distribution | |
| VK.J1105QRS | In distribution | |
| VK.804RHE | In distribution | |
| VK.J801QRS | In distribution | |
| VK.J701QRS | In distribution | |
| VK.J1002CTBC | In distribution | |
| VK.J705QR90 | In distribution | |
| VK.J904CTBD | In distribution | |
| VK.J704CT | In distribution | |
| VK.J701CTS | In distribution | |
| VK.J1002QR | In distribution | |
| VK.J1303CT | In distribution | |
| VK.J804CT | In distribution | |
| VK.J801QR | In distribution | |
| VK.J8006QR | In distribution | |
| VK.J703CTSC | In distribution | |
| VK.J1104CTS | In distribution | |
| VK.J1103CT | In distribution | |
| VK.J905CT | In distribution | |
| VK.J903CT | In distribution | |
| VK.J1104QRS | In distribution | |
| VK.J704QR90 | In distribution | |
| VK.J803CT | In distribution | |
| VK.J803QRS | In distribution | |
| VK.J1202CT | In distribution | |
| VK.J903QRBC | In distribution | |
| VK.J802CVUQR | In distribution | |
| VK.J1104CT90 | In distribution | |
| VK.J803CTS | In distribution | |
| VK.J904CTS | In distribution | |
| VK.J802QRF | In distribution | |
| VK.J803CVRQR | In distribution | |
| VK.J804CVUQR | In distribution | |
| VK.J802CTBD90 | In distribution | |
| VK.J901QRBC | In distribution | |
| VK.J905CTS | In distribution | |
| VK.J901CT | 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.