Integra®
Integra® Derlacki Chisel, Angle 10 Degree, Narrow Edge, 0.5 mm Wide
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | JYE |
| Device type | Chisel, Middle-Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2024-02-28 (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, manufacturing date |
| Sizes | Width 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3722155 | In distribution | |
| 3722154 | In distribution | |
| 3722009 | 6-1/2″ | In distribution |
| 3722073 | 6-1/2″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 9 |
| Aesculap | Aesculap AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 6 |
| GEN2 | Surgix Medical LLC | 5 |
| MicroFrance® | Integra Microfrance SAS | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| V. Mueller | Steris Corporation | 2 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Jedmed | Jedmed Instrument Company | 1 |
| Symmetry House | Aspen Surgical Products, Inc. | 1 |
Showing 12 of 13. All products under Chisel, Middle-Ear
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.