Integra® Miltex®
Curette, Gracey 15-16, Double-Ended, Round Handle
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKT |
| Device type | Curette, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-18 |
| Record revised | 2020-07-21 (version 4) |
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 |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 017-44507 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ACE | Ace Surgical Supply Co., Inc. | 29 |
| Millennium | Avalign Technologies, Inc. | 19 |
| Pilling | Teleflex Medical LLC | 8 |
| Avalign | Avalign Technologies, Inc. | 8 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 7 |
| TBS Basics | Acme Enterprise. | 4 |
| Adler Instrument Company | Adler, Inc. | 3 |
| Symmetry Lucas | Aspen Surgical Products, Inc. | 2 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 2 |
| devemed | Devemed Gmbh | 2 |
| Symmetry Molt | Aspen Surgical Products, Inc. | 1 |
| Reicodent | Devemed Gmbh | 1 |
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.