OsteoMed
SmartFlex 5mm Rongeur
1manufacturer
1catalogue number
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 | Osteomed, United States |
|---|---|
| FDA product code | HAE |
| Device type | Rongeur, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4840 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-07-21 |
| Record revised | 2018-03-29 (version 2) |
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, manufacturing date |
| Storage | Handling environment temperature up to 275 °F; Special storage condition: Store at a controlled room temperature between 15ºC to 30ºC (59ºF to 86ºF). |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220-0772 | 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 |
|---|---|
| K131851 | 2013-12-06 |
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.