Rongeur, Manual
CERAMO bayo punch with ejector fl. ft, 2.0x200mm, work.length
1manufacturer
383catalogue 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 | Fehling Instruments GmbH, Germany |
|---|---|
| FDA product code | HAE |
| Device type | Rongeur, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4840 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K153243 |
| Record published | 2018-08-03 |
| Record revised | 2019-07-17 (version 4) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NNL-6A | In distribution | |
| TIB-3 | In distribution | |
| NTI-9S | In distribution | |
| NVF-2S | In distribution | |
| TGC-1 | In distribution | |
| NNT-1S | In distribution | |
| TGZ-6A | In distribution | |
| NVC-2 | In distribution | |
| TIB-5 | In distribution | |
| TEA-4 | In distribution | |
| NNU-3S | In distribution | |
| NNL-3X | In distribution | |
| NNN-4A | In distribution | |
| TEB-5 | In distribution | |
| NVA-4S | In distribution | |
| TGP-8 | In distribution | |
| TEE-1 | In distribution | |
| NZT-7S | In distribution | |
| NNU-1X | In distribution | |
| NZL-0S | In distribution | |
| NNN-3S | In distribution | |
| NNA-3S | In distribution | |
| TEA-0 | In distribution | |
| TEA-3 | In distribution | |
| TEJ-4 | In distribution | |
| NTI-0X | In distribution | |
| TEB-3X | In distribution | |
| TGW-0 | In distribution | |
| NVZ-8S | In distribution | |
| TEJ-6 | In distribution | |
| NNN-3X | In distribution | |
| THE-4 | In distribution | |
| TGC-3 | In distribution | |
| TGC-2 | In distribution | |
| TEF-4X | In distribution | |
| NNL-4A | In distribution | |
| TEF-3 | In distribution | |
| NNO-5X | In distribution | |
| THE-5 | In distribution | |
| NNQ-9S | In distribution | |
| TGA-2 | In distribution | |
| NTH-7S | In distribution | |
| NNO-7X | In distribution | |
| NNS-4S | In distribution | |
| TIG-5 | In distribution | |
| NNL-4X | In distribution | |
| NNG-8S | In distribution | |
| NNO-2F | In distribution | |
| TNC-6S | In distribution | |
| NNQ-1X | In distribution | |
| NNS-0S | In distribution | |
| TEF-4 | In distribution | |
| NND-2 | In distribution | |
| NNJ-7S | In distribution | |
| NVZ-0S | In distribution | |
| NNK-8X | In distribution | |
| NNL-6X | In distribution | |
| TGL-8 | In distribution | |
| TEB-7 | In distribution | |
| NNL-1X | In distribution | |
| TNA-3S | In distribution | |
| NNG-5S | In distribution | |
| NNL-0X | In distribution | |
| NNI-7S | In distribution | |
| NVC-4 | In distribution | |
| NNR-2 | In distribution | |
| NTI-8S | In distribution | |
| TEE-3 | In distribution | |
| NNL-9S | In distribution | |
| NNL-2S | In distribution | |
| NNE-5S | In distribution | |
| THD-1 | In distribution | |
| NVD-1S | In distribution | |
| NNY-3X | In distribution | |
| TIB-4 | In distribution | |
| TEJ-3 | In distribution | |
| NNN-1S | In distribution | |
| TEF-5 | In distribution | |
| NVA-5X | In distribution | |
| NNE-4X | In distribution | |
| NVA-9S | In distribution | |
| NNL-1A | In distribution | |
| NNU-9S | In distribution | |
| TEH-1X | In distribution | |
| NNU-4S | In distribution | |
| NNR-6 | In distribution | |
| NVF-8A | In distribution | |
| NVF-4S | In distribution | |
| TEE-5 | In distribution | |
| NZK-1S | In distribution | |
| NVZ-7S | In distribution | |
| NNO-7A | In distribution | |
| NNR-0X | In distribution | |
| NNK-8F | In distribution | |
| NVZ-6S | In distribution | |
| NNL-6S | In distribution | |
| NNL-8S | In distribution | |
| NNW-4S | In distribution | |
| NTH-1 | In distribution | |
| NNR-0S | In distribution | |
| NNP-1S | In distribution | |
| NNG-1X | In distribution | |
| NNU-9X | In distribution | |
| TEA-3X | In distribution | |
| NUZ-9X | In distribution | |
| TEJ-2 | In distribution | |
| NNY-5X | In distribution | |
| NYC-2X | In distribution | |
| TEK-4X | In distribution | |
| NNK-9S | In distribution | |
| NZY-9A | In distribution | |
| THB-2 | In distribution | |
| NVU-0A | In distribution | |
| NNN-0S | In distribution | |
| NFV-3S | In distribution | |
| NNO-3X | In distribution | |
| NNA-2S | In distribution | |
| NNM-3S | In distribution | |
| NNW-3X | In distribution | |
| TEB-3 | In distribution | |
| TGB-7 | In distribution | |
| NNN-2S | In distribution | |
| NNO-1A | In distribution | |
| NZY-8A | In distribution | |
| NNY-0A | In distribution | |
| NZA-3S | In distribution | |
| NVD-6S | In distribution | |
| NNL-3S | In distribution | |
| TEA-7 | In distribution | |
| NNG-7A | In distribution | |
| NNG-1S | In distribution | |
| NVD-0X | In distribution | |
| NVB-7S | In distribution | |
| TEB-2 | In distribution | |
| TGA-1 | In distribution | |
| TEF-3X | In distribution | |
| TEA-5 | In distribution | |
| NNL-3A | In distribution | |
| TEB-2X | In distribution | |
| NNO-2S | In distribution | |
| NNM-9S | In distribution | |
| TRB-7X | In distribution | |
| NNG-7X | In distribution | |
| TEJ-1 | In distribution | |
| NLF-2S | In distribution | |
| NNN-5X | In distribution | |
| NVZ-7X | In distribution | |
| NVU-0S | In distribution | |
| NVF-4A | In distribution | |
| TEA-1X | In distribution | |
| NNO-1F | In distribution | |
| TIG-2 | In distribution | |
| NNL-7S | In distribution | |
| TGB-8 | In distribution | |
| NVD-6X | In distribution | |
| TGA-4 | In distribution | |
| THE-1 | In distribution | |
| NNN-5S | In distribution | |
| NNU-8S | In distribution | |
| NVF-7A | In distribution | |
| NZX-9S | In distribution | |
| TEB-1X | In distribution | |
| TGD-5 | In distribution | |
| NZY-9X | In distribution | |
| NNO-8X | In distribution | |
| TRO-0F | In distribution | |
| TGB-4 | In distribution | |
| TGB-1 | In distribution | |
| NVF-3S | In distribution | |
| THE-3 | In distribution | |
| TEA-6X | In distribution | |
| TGB-3 | In distribution | |
| NNE-3X | In distribution | |
| TGD-3 | In distribution | |
| NNN-4S | In distribution | |
| TEA-2X | In distribution | |
| NVA-8S | In distribution | |
| TIG-6 | In distribution | |
| NNG-4S | In distribution | |
| NNL-0S | In distribution | |
| NNW-5S | In distribution | |
| NUZ-9S | In distribution | |
| NNW-3A | In distribution | |
| NZK-3S | In distribution | |
| NNO-1S | In distribution | |
| NNW-3S | In distribution | |
| NNY-3S | In distribution | |
| NZA-2S | In distribution | |
| TEA-5X | In distribution | |
| TGD-1 | In distribution | |
| TXW-9X | In distribution | |
| TEA-4X | In distribution | |
| TGB-6 | In distribution | |
| NNG-7S | In distribution | |
| NZY-8F | In distribution | |
| NND-3 | In distribution | |
| TGD-7 | In distribution | |
| NNR-9 | In distribution | |
| NNY-0S | In distribution | |
| NVZ-2S | In distribution | |
| TGF-3 | In distribution | |
| NNU-8X | In distribution | |
| NNX-0X | In distribution | |
| THD-5 | In distribution | |
| NNK-9X | In distribution | |
| NNL-4S | In distribution | |
| NNB-9S | In distribution | |
| NNN-1X | In distribution | |
| NVZ-0X | In distribution | |
| NND-4 | In distribution | |
| NNL-6F | In distribution | |
| NVD-1X | In distribution | |
| NNQ-3X | In distribution | |
| NNO-3S | In distribution | |
| TEJ-5 | In distribution | |
| NNS-2S | In distribution | |
| NNN-0A | In distribution | |
| NZA-4S | In distribution | |
| NVA-5S | In distribution | |
| NNE-5X | In distribution | |
| NNK-9A | In distribution | |
| TEF-5X | In distribution | |
| TGF-1 | In distribution | |
| NNE-4S | In distribution | |
| NNL-1S | In distribution | |
| NNY-5S | In distribution | |
| NNA-5S | In distribution | |
| NNX-0S | In distribution | |
| TEF-2X | In distribution | |
| TEK-3X | In distribution | |
| TGZ-0 | In distribution | |
| TEB-4X | In distribution | |
| TIB-2 | In distribution | |
| NNK-9F | In distribution | |
| TEF-1 | In distribution | |
| NNO-0X | In distribution | |
| NVZ-6X | In distribution | |
| THD-3 | In distribution | |
| TRB-1F | In distribution | |
| TEB-1 | In distribution | |
| NNW-2S | In distribution | |
| NNA-1S | In distribution | |
| TEF-1X | In distribution | |
| NNX-4X | In distribution | |
| NTI-0S | In distribution | |
| NNJ-9X | In distribution | |
| NZY-8X | In distribution | |
| NZY-8S | In distribution | |
| NNX-4S | In distribution | |
| NVZ-3S | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Quick Release | Vitalitec International Medizintechnik GmbH | 218 |
Showing 12 of 158. All products under Rongeur, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153243 | 2016-08-04 |
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.