Aesculap
ROSEN Micro Ear Needle, curved, 6 1/4", (160 mm), sharp, No. 7, non-sterile, reusable
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Jiangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiujiang Meite Jewelry Co..Ltd. | Jiujiang | Jiangxi | Manufacturer | 3 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KAT |
| Device type | Perforator, Antrum |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-22 |
| Record revised | 2023-08-25 (version 5) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OG001R | In distribution | |
| OG003R | In distribution | |
| OG070R | In distribution | |
| OG075R | In distribution | |
| OF608R | In distribution | |
| OG002R | In distribution | |
| OG072R | In distribution | |
| OG073R | In distribution | |
| OF610R | In distribution | |
| OG071R | In distribution | |
| OG005R | In distribution | |
| OG074R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 3 |
| Perforator, Antrum | Biomet Microfixation | 1 |
| V. Mueller | Carefusion 2200, Inc. | 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.