AtriCure System Cart
Packaged Cryo Cart KIT Assembly - Single Tank
5manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (1), Shaanxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Visuscience Meditech Co., Ltd. | Wuxi | Jiangsu | Specification developer | 9 |
Record
| Listed by | Atricure, Inc., United States |
|---|---|
| FDA product code | HMF |
| Device type | Stand, Instrument, Ac-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1860 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-01-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -35 to 54 °C; Storage environment humidity 15 to 90 % RH |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASCC2 | In distribution | |
| ASCB | In distribution | |
| ASC1 | In distribution | |
| ASCF | In distribution | |
| ASCS | In distribution | |
| ASCS | In distribution | |
| ASCC-400 | In distribution | |
| ASC2 | In distribution | |
| ASCO | In distribution | |
| ASCB2 | In distribution | |
| ASCB | In distribution | |
| ASCC | In distribution | |
| ASCC-400 | In distribution | |
| ASCB2 | In distribution | |
| ASCO | In distribution | |
| ASCC2 | In distribution | |
| ASCF | In distribution | |
| ASCO | In distribution | |
| ASCB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Reliance | Haag-Streit USA, Inc. | 19 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 13 |
| Refraction Unit | MDT SP. Z O.O. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 10 |
| Marco | Takagi Seiko Co., Ltd. | 7 |
| Mckesson | Mckesson Medical-Surgical Inc. | 6 |
| IS-5500 | Topcon Corp. | 5 |
| IS-5000 | Topcon Corp. | 2 |
| KXL System | Avedro, Inc. | 2 |
| IS-6500 | Topcon Corp. | 2 |
| Legion | Alcon Laboratories, Inc. | 1 |
| i.Terminal 2 Station | Carl Zeiss Vision Gmbh | 1 |
Showing 12 of 19. All products under Stand, Instrument, Ac-Powered, Ophthalmic
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.