Aesculap
CASTROVIEJO Micro Needle Holder, straight, 5 3/8", (137 mm), (10 mm), flat handle, without ratchet, non-sterile, reusable
4manufacturers in China registered for this device type
20catalogue 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 | Aesculap AG, Germany |
|---|---|
| FDA product code | HNM |
| Device type | Needle, Ophthalmic Suturing |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-05-07 |
| Record revised | 2021-01-08 (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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MA354R | In distribution | |
| MA910R | In distribution | |
| MA360R | In distribution | |
| MA363R | In distribution | |
| MA352R | In distribution | |
| MA364R | In distribution | |
| MA355R | In distribution | |
| MA367R | In distribution | |
| MA907R | In distribution | |
| MA351R | In distribution | |
| MA365R | In distribution | |
| MA909R | In distribution | |
| MA358R | In distribution | |
| MA368R | In distribution | |
| MA908R | In distribution | |
| MA366R | In distribution | |
| MA356R | In distribution | |
| MA628R | In distribution | |
| MA353R | In distribution | |
| MA357R | 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 |
| Duckworth & Kent | Duckworth AND Kent Limited | 19 |
| Pilling | Teleflex Medical LLC | 19 |
| Moria | Moria, Inc. | 18 |
| Avalign | Avalign Technologies, Inc. | 12 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 10 |
| 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.