Hook
Jannetta, NO. 2, 45* UP
6manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (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 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | GZX |
| Device type | Instrument, Microsurgical |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4525 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2024-08-26 (version 5) |
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 |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24-841-02-07 | 21 CM | In distribution |
| 24-848-01-07 | 21 CM | In distribution |
| 24-841-01-07 | 21 CM | In distribution |
| 24-848-02-07 | 21 CM | In distribution |
| 995-5826-01 | 23 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 759 |
| Ambler Surgical | Ambler Surgical, LLC | 456 |
| Spetzler MacroVac® | PMT Corp. | 405 |
| Boss Instruments | Boss Instruments, Ltd. | 311 |
| Dissector | KLS-Martin L.P. | 281 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 229 |
| Macrovac® | PMT Corp. | 190 |
| Avalign | Avalign Technologies, Inc. | 186 |
| Millennium | Avalign Technologies, Inc. | 173 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 170 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 168 |
| V. Mueller | Steris Corporation | 156 |
Showing 12 of 114. All products under Instrument, Microsurgical
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.