Medetz Surgical Instruments
Castroviejo Needle Holder Standard Straight 11mm Smooth Jaws, With Lock, Flat Serrated Handle, 140mm Overall Length, Stainless Steel
4manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Medetz Surgical Instruments, United States |
|---|---|
| FDA product code | HNM |
| Device type | Needle, Ophthalmic Suturing |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-02-24 |
| Record revised | 2023-07-17 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11-2737 | In distribution | |
| 11-2750 | In distribution | |
| 11-2750whmc | In distribution | |
| 11-2794 | In distribution | |
| 12-50479 | In distribution | |
| T11-2750 | In distribution | |
| 12-52929 | In distribution | |
| 11-2796w | In distribution | |
| 11-2725c | In distribution | |
| 11-3850 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 50 |
| MR Phaco | Crestpoint Management Ltd. | 37 |
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 36 |
| V. Mueller | Steris Corporation | 22 |
| Aesculap | Aesculap AG | 20 |
| Duckworth & Kent | Duckworth AND Kent Limited | 19 |
| Pilling | Teleflex Medical LLC | 19 |
| Moria | Moria, Inc. | 18 |
| Avalign | Avalign Technologies, Inc. | 12 |
| Novo Surgical | Novo Surgical, Inc. | 7 |
| Barraquer Needle Holder, Curved | Bausch & Lomb Incorporated | 6 |
| Castroviejo Needle Holder, Straight | Bausch & Lomb Incorporated | 5 |
Showing 12 of 31. All products under Needle, Ophthalmic Suturing
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.