Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
2.0MM Three-Fluted Radiolucent Drill BIT/Brad POINT/150MM
1manufacturer
46catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HSZ |
| Device type | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-21 |
| Record revised | 2026-04-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310.221 | In distribution | |
| 310.572 | In distribution | |
| 315.23S | In distribution | |
| 310.26 | In distribution | |
| 316.232 | In distribution | |
| 511.411 | In distribution | |
| 310.45S | In distribution | |
| 519.50 | In distribution | |
| 316.292 | In distribution | |
| 310.60J | In distribution | |
| 310.32 | In distribution | |
| 310.634 | In distribution | |
| 310.16 | In distribution | |
| 519.51 | In distribution | |
| 310.44S | In distribution | |
| 310.21JS | In distribution | |
| 316.396 | In distribution | |
| 310.48 | In distribution | |
| 513.14 | In distribution | |
| 310.29S | In distribution | |
| 315.05S | In distribution | |
| 310.36S | In distribution | |
| 310.48S | In distribution | |
| 310.153 | In distribution | |
| 316.294 | In distribution | |
| 310.35S | In distribution | |
| 310.19 | In distribution | |
| 310.23 | In distribution | |
| 513.01 | In distribution | |
| 310.31 | In distribution | |
| 315.31S | In distribution | |
| 315.26S | In distribution | |
| 310.201S | In distribution | |
| 310.20S | In distribution | |
| 310.221S | In distribution | |
| 310.14 | In distribution | |
| 310.229 | In distribution | |
| 310.111 | In distribution | |
| 519.53 | In distribution | |
| 310.45 | In distribution | |
| 310.23S | In distribution | |
| 310.15S | In distribution | |
| 310.15 | In distribution | |
| 310.113 | In distribution | |
| 511.431 | In distribution | |
| 310.35 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 161 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Anspach Effort, The | 56 |
| MicroAire® | Microaire Surgical Instruments LLC | 27 |
| Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | Exactech, Inc. | 16 |
| Corb® | Zimmer, Inc. | 13 |
| Nucleotome | Clarus Medical, LLC. | 4 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| Curvtek Cartridge | Biomet Orthopedics | 3 |
| Remover | Hankil Tech Medical Co., Ltd. | 3 |
| Micro Potuitary Forceps | Hankil Tech Medical Co., Ltd. | 2 |
| Curvtek EYE Needle | Biomet Orthopedics | 2 |
| Powerpro | ConMed Corporation | 2 |
Showing 12 of 25. All products under Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | UDI-DI | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 17 units |
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.