Bur, Surgical, General & Plastic Surgery
1.4 mm x 12.8 mm Fluted Router. Use with B-TURQUOISE, B-TURQ-X, or B- TURQ-CDA Attachments.
7manufacturers in China registered for this device type
66catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zonefly Medical Devices Co., Ltd. | Danyang | Jiangsu | Specification developer | 7 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 6 |
Record
| Listed by | Anspach Effort, The |
|---|---|
| FDA product code | GFF |
| Device type | Bur, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| 510(k) | K974025 |
| Record published | 2016-09-09 |
| Record revised | 2022-05-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ORNG-33 | Withdrawn | |
| BLU-51 | Withdrawn | |
| GOL-2 | Withdrawn | |
| BLU-17-2 | Withdrawn | |
| VIO-8 | Withdrawn | |
| VIO-2 | Withdrawn | |
| TURQ-4 | Withdrawn | |
| ORNG-1 | Withdrawn | |
| TURQ-6 | Withdrawn | |
| BLA-24 | Withdrawn | |
| BLA-8 | Withdrawn | |
| BLA-5 | Withdrawn | |
| BLA-10 | Withdrawn | |
| RED-2 | Withdrawn | |
| VIO-17-3 | Withdrawn | |
| BLU-24 | Withdrawn | |
| VIO-32 | Withdrawn | |
| VIO-5 | Withdrawn | |
| BLA-7 | Withdrawn | |
| BLU-10 | Withdrawn | |
| BLU-14 | Withdrawn | |
| BLA-38 | Withdrawn | |
| BLU-4 | Withdrawn | |
| GRE-1 | Withdrawn | |
| TURQ-17-3 | Withdrawn | |
| BLU-17-4 | Withdrawn | |
| TURQ-1 | Withdrawn | |
| BLU-9 | Withdrawn | |
| RED-9 | Withdrawn | |
| SIL-0 | Withdrawn | |
| SIL-DS-A | Withdrawn | |
| BLU-8 | Withdrawn | |
| SIL-3-10 | Withdrawn | |
| TURQ-3 | Withdrawn | |
| BLU-1 | Withdrawn | |
| BLU-LS9-5 | Withdrawn | |
| VIO-17-4 | Withdrawn | |
| VIO-38 | Withdrawn | |
| BLA-6 | Withdrawn | |
| BLA-51 | Withdrawn | |
| RED-32 | Withdrawn | |
| RED-8 | Withdrawn | |
| TURQ-436-6 | Withdrawn | |
| BLU-6 | Withdrawn | |
| BLA-2 | Withdrawn | |
| GOL-2S | Withdrawn | |
| TURQ-434-4 | Withdrawn | |
| TURQ-8 | Withdrawn | |
| BLA-9 | Withdrawn | |
| BLU-38 | Withdrawn | |
| VIO-6 | Withdrawn | |
| BLU-17-1 | Withdrawn | |
| BLU-5 | Withdrawn | |
| GRE-1S | Withdrawn | |
| BLU-39 | Withdrawn | |
| VIO-24 | Withdrawn | |
| BLU-32 | Withdrawn | |
| TURQ-406-6 | Withdrawn | |
| VIO-4 | Withdrawn | |
| BLU-17-3 | Withdrawn | |
| ORNG-36 | Withdrawn | |
| TURQ-5 | Withdrawn | |
| ORNG-35 | Withdrawn | |
| BLA-32 | Withdrawn | |
| BLA-1 | Withdrawn | |
| BLU-7 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Komet Surgical Bur | Gebr. Brasseler Gmbh & Co. KG | 1,011 |
| Bur, Surgical, General & Plastic Surgery | Sterilmed, Inc. | 1,001 |
| Medline | Medline Industries, Inc. | 584 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 335 |
| Bur, Surgical, General & Plastic Surgery | Omega Surgical Instruments, Inc. | 312 |
| Bur, Surgical, General & Plastic Surgery | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 170 |
| MicroAire® | Microaire Surgical Instruments LLC | 162 |
| Ultrapower | ConMed Corporation | 155 |
| De Soutter Medical | DE Soutter Medical Ltd. | 143 |
| Jota | Jota AG | 112 |
| Conmed | ConMed Corporation | 109 |
| Bur, Round, round shank | Gebr. Brasseler Gmbh & Co. KG | 104 |
Showing 12 of 167. All products under Bur, Surgical, General & Plastic Surgery
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| THE Anspach Effort, Inc. | 510(k) number | 2016-10-06 | Class II | Under Investigation by firm | Supplied Directions for Use (DFU) did not contain a recommended service interval. | 41 | 2019-07-26 |
| THE Anspach Effort, Inc. | 510(k) number | 2011-03-31 | Class II | Pending | Cutter was longer than was stated on the label | 29 cutting burs | 2019-07-18 |
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.