Aesculap
Redon Spike, slightly curved, 7 1/2", (190 mm), diam. Charr. 14, triangular tip, non-sterile, reusable, threaded
8manufacturers in China registered for this device type
38catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Shanghai (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 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | EMF |
| Device type | Knife, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| 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 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-08-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FD351R | In distribution | ||
| FD353R | In distribution | ||
| BA718R | 10 | In distribution | |
| FD347R | In distribution | ||
| FD298R | In distribution | ||
| FD864R | In distribution | ||
| BB331R | 10 | In distribution | |
| BA711R | 50 | In distribution | |
| BA708R | In distribution | ||
| FD410R | In distribution | ||
| FD350R | In distribution | ||
| FD412R | In distribution | ||
| FD365R | In distribution | ||
| FD362R | In distribution | ||
| MG575R | In distribution | ||
| BA714R | 10 | In distribution | |
| BN945R | In distribution | ||
| FD354R | In distribution | ||
| OG131R | In distribution | ||
| MG717R | In distribution | ||
| BA712R | In distribution | ||
| FD418R | In distribution | ||
| FD352R | In distribution | ||
| FD411R | In distribution | ||
| BA706R | In distribution | ||
| FD416R | In distribution | ||
| BN905R | In distribution | ||
| FD415R | In distribution | ||
| MD025 | In distribution | ||
| OF601R | In distribution | ||
| FD366R | In distribution | ||
| BA719R | In distribution | ||
| FD866R | In distribution | ||
| FD413R | In distribution | ||
| FD414R | In distribution | ||
| BB332R | 10 | In distribution | |
| FD861R | In distribution | ||
| FD868R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgistar | Surgistar, Inc. | 285 |
| Surtex | Surtex Instruments Ltd | 189 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 80 |
| Zoll-Dental | Zoll-Dental | 72 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 59 |
| Lazic | Peter Lazic Gmbh | 47 |
| Millennium | Avalign Technologies, Inc. | 40 |
| Sklar | Sklar Corporation | 35 |
| Stylus | Surgical Specialties México, S. de R.L. de C.V. | 32 |
| V. Mueller | Steris Corporation | 31 |
| Elmed | Elmed, Inc. | 30 |
| Gimmi | Gimmi Gmbh | 24 |
Showing 12 of 122. All products under Knife, Surgical
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.