Surgical Direct
3mm Biopsy Cup Forcep, Straight
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
Record
| Listed by | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | KFT |
| Device type | Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-04-28 |
| Record revised | 2024-04-17 (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 |
| Sizes | Outer diameter 3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD27659 | Outer Diameter 3 mm | In distribution |
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.