Boss Instruments
Delacki Chisel, sltly ang 20deg,nrrw edge,.5mm wid
2manufacturers in China registered for this device type
9catalogue 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 | Boss Instruments, Ltd., United States |
|---|---|
| FDA product code | JYE |
| Device type | Chisel, Middle-Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-28 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90-3806 | In distribution | |
| 90-3013 | In distribution | |
| 90-3805 | In distribution | |
| 90-3346 | In distribution | |
| 90-3347 | In distribution | |
| 90-3804 | In distribution | |
| 90-3338 | In distribution | |
| 90-3807 | In distribution | |
| 90-3339 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 6 |
| GEN2 | Surgix Medical LLC | 5 |
| Integra® | Integra LifeSciences Production Corporation | 4 |
| 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.