Cook
Fascial Incising Needle Use with wire guide .038
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | FHR |
| Device type | Needle, Gastro-Urology |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
| Record revised | 2021-07-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G14519 | In distribution | |
| G53740 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Carefusion 2200, Inc. | 7 |
| V. Mueller | Steris Corporation | 3 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 2 |
| Avalign | Avalign Technologies, Inc. | 1 |
| Millennium | Avalign Technologies, Inc. | 1 |
| Pilling | Teleflex Medical LLC | 1 |
| Rigid Needle 21 GA x 0.5″ (0,8 x 13 mm) | Merz North America, Inc. | 1 |
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.