QFlow 500 2.7mm Drill Bit Kit
2.7mm Drill Bit Kit
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Hemedex Incorporated, United States |
|---|---|
| FDA product code | HBG |
| Device type | Drills, Burrs, Trephines & Accessories (Manual) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4300 |
| Establishment | Manufacturer |
| 510(k) | K141869 |
| Record published | 2016-09-21 |
| Record revised | 2018-11-22 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 508 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 172 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 65 |
| Drills, Burrs, Trephines & Accessories (Manual) | Synthes Gmbh | 34 |
| Integra® | Integra Pain Management | 7 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 6 |
| Symmetry Hudson | Aspen Surgical Products, Inc. | 5 |
| Symmetry Cushing | Aspen Surgical Products, Inc. | 4 |
| V. Mueller | Steris Corporation | 3 |
| SmartTip | ClearPoint Neuro Inc. | 3 |
| Drill Bit | Neurovention, LLC | 2 |
| Codman® | Integra LifeSciences Production Corporation | 2 |
Showing 12 of 41. All products under Drills, Burrs, Trephines & Accessories (Manual)
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.