Millennium
Tenolysis Knives, Set of , double-ended knives and dilator
8manufacturers in China registered for this device type
40catalogue 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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | EMF |
| Device type | Knife, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-01 |
| Record revised | 2023-07-06 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-110180 | In distribution | |
| 1-400260 | In distribution | |
| 1-225413C | In distribution | |
| 1-80112 | In distribution | |
| 1-80114 | In distribution | |
| 1-410196 | In distribution | |
| 1-225412 | In distribution | |
| 1-400264 | In distribution | |
| 1-400261 | In distribution | |
| 85-76082628 | In distribution | |
| 1-545110 | In distribution | |
| 1-27974 | In distribution | |
| 1-27972 | In distribution | |
| 1-400263 | In distribution | |
| 1-80131311 | In distribution | |
| 1-80110 | In distribution | |
| 1-801314 | In distribution | |
| 1-801313 | In distribution | |
| 1-545113 | In distribution | |
| 1-882012 | In distribution | |
| 1-8011 | In distribution | |
| 1-545111 | In distribution | |
| 1-BKS | In distribution | |
| 1-545112 | In distribution | |
| 1-225413 | In distribution | |
| 72-426884 | In distribution | |
| 1-271600 | In distribution | |
| 72-426882 | In distribution | |
| 1-1128 | In distribution | |
| 1-FO856RC | In distribution | |
| 1-80118 | In distribution | |
| 1-400255 | In distribution | |
| 1-110182 | In distribution | |
| 11-OG101R | In distribution | |
| 1-80111 | In distribution | |
| 1-6680 | In distribution | |
| 1-450415 | In distribution | |
| 14-882135 | In distribution | |
| 1-3601001 | In distribution | |
| 1-BKL | In distribution |
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 |
| Aesculap | Aesculap AG | 38 |
| 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.