SmartTip
SmartTip MRII Drill Kit, 3.2-mm
2manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | ClearPoint Neuro Inc., 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) | K160129 |
| Record published | 2021-01-22 |
| Record revised | 2024-03-22 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 3.2 mm |
| Distribution end date | 2024-03-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NGS-DB-45-S | In distribution | |
| NGS-DB-45 | In distribution | |
| NGS-DB-01 | Outer Diameter 3.2 mm | Withdrawn |
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 |
| Drill Bit | Neurovention, LLC | 2 |
| Codman® | Integra LifeSciences Production Corporation | 2 |
| Disposable Drill Kit | AD-Tech Medical Instrument Corp. | 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.