Aesculap
GWYNNE EVANS Tonsil Dissector, 8", (200 mm), double ended, width: 8 mm, non-sterile, reusable
4manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (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 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | KBM |
| Device type | Dissector, Tonsil |
| 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 | 2025-03-04 (version 2) |
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 |
| Distribution end date | 2025-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OM660R | In distribution | |
| OM664R | In distribution | |
| OM665R | In distribution | |
| OM666R | In distribution | |
| OM661R | In distribution | |
| OM668R | In distribution | |
| OM663R | In distribution | |
| MA289R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 77 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 7 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 5 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 4 |
| Dissector | KLS-Martin L.P. | 3 |
| Dissector, Tonsil | Biomet Microfixation | 2 |
| Gimmi | Gimmi Gmbh | 2 |
| BR Surgical, LLC | BR Surgical LLC | 2 |
| Symmetry Lillie | Aspen Surgical Products, Inc. | 1 |
| V. Mueller | Carefusion 2200, Inc. | 1 |
| Knife | KLS-Martin L.P. | 1 |
| V. Mueller | Steris Corporation | 1 |
Showing 12 of 16. All products under Dissector, Tonsil
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.