MicroFrance®
MicroFrance® Stenstrom otoabrader curved rasp, right, 160 mm length
2manufacturers in China registered for this device type
7catalogue 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 Microfrance SAS, France |
|---|---|
| FDA product code | JYY |
| Device type | Rasp, Ear |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-12 |
| Record revised | 2023-05-12 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MCO224G | In distribution | |
| MCO9-1 | In distribution | |
| MCO224A-2-0 | In distribution | |
| MCO224-2-0 | In distribution | |
| CP85L | In distribution | |
| MCO979 | In distribution | |
| CP85R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 11 |
| Pilling | Teleflex Medical LLC | 7 |
| Sontec EAR Raspatory | Sontec Instruments, Inc. | 5 |
| Integra® | Integra LifeSciences Production Corporation | 5 |
| Millennium | Avalign Technologies, Inc. | 4 |
| Aesculap | Aesculap AG | 4 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 4 |
| Hayden Medical | Hayden Medical Inc | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| V. Mueller | Steris Corporation | 3 |
| Avalign | Avalign Technologies, Inc. | 3 |
| Kistler EAR Cartilage Raspatory | Sontec Instruments, Inc. | 2 |
Showing 12 of 21. All products under Rasp, 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.