Aesculap
KERRISON Bone Punch conventional, 130 °, upwards cutting, 7 7/8", (200 mm), width: 3 mm, opening width: 10 mm, detachable, with ejector, thin, non-sterile, reusable
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | GXJ |
| Device type | Punch, Skull |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-17 |
| Record revised | 2021-10-19 (version 3) |
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 |
|---|---|---|
| FK963R | In distribution | |
| FF113R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Punch | KLS-Martin L.P. | 2 |
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.