Heart Stabilizer Finger Attachment
Heartline Heart Stabilizer Finger Attachment 2S-TWO Short Fingers (401-212S)
9manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Beijing (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Maquet (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 6 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Beijing Yuewei Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | MWS |
| Device type | Stabilizer, Heart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2016-08-26 |
| Record revised | 2021-05-10 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2018-09-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2800-828 | In distribution | |
| 2800-826 | In distribution | |
| 2800-830 | In distribution | |
| 2800-826 | Withdrawn | |
| 2800-828 | Withdrawn | |
| 2800-830 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Octopus® | Medtronic, Inc. | 11 |
| Heartline Stabilizer Arm | Sontec Instruments, Inc. | 6 |
| Starfish™ | Medtronic, Inc. | 4 |
| Stabilizer Tips | Sontec Instruments, Inc. | 4 |
| Urchin® | Medtronic, Inc. | 3 |
| Acrobat-I Stabilizer | Maquet Cardiovascular LLC | 2 |
| Viper II Heart Stabilizer | KDL Medical, Inc. | 2 |
| Viper II Apical Lift | KDL Medical, Inc. | 2 |
| Acrobat-i Positioner | Maquet Cardiovascular LLC | 2 |
| Acrobat SUV Stabilizer | Maquet Cardiovascular LLC | 2 |
| Starfish® EVO | Medtronic, Inc. | 2 |
| Heartline Stabilizer ARM Clamp | Sontec Instruments, Inc. | 1 |
Showing 12 of 36. All products under Stabilizer, Heart
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.