Millennium
Anis Needle Holder w/o lock, Extra Delicate, Straight OL125mm (4 7/8")
4manufacturers in China registered for this device type
50catalogue 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 | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | HNM |
| Device type | Needle, Ophthalmic Suturing |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-17 |
| Record revised | 2023-07-06 (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 |
|---|---|---|
| 10-355409 | In distribution | |
| 4-61030 | In distribution | |
| 3-3834WO | In distribution | |
| 4-61580 | In distribution | |
| 3-3836C | In distribution | |
| 3-3861WH | In distribution | |
| 85-72010794 | In distribution | |
| 4-63830 | In distribution | |
| 4-63630 | In distribution | |
| 1-278093L | In distribution | |
| 3-3835 | In distribution | |
| 85-116 | In distribution | |
| 3-3861WHMC | In distribution | |
| 4-63250 | In distribution | |
| 3-3843 | In distribution | |
| 3-3839 | In distribution | |
| 4-63310 | In distribution | |
| 85-72010874 | In distribution | |
| 85-809803 | In distribution | |
| 4-63620 | In distribution | |
| 85-114 | In distribution | |
| 4-63800 | In distribution | |
| 3-3842 | In distribution | |
| 3-3804WLM | In distribution | |
| 3-3862 | In distribution | |
| 3-3849 | In distribution | |
| 3-3828SWO | In distribution | |
| 3-3828CWO | In distribution | |
| 3-3864 | In distribution | |
| 4-63000 | In distribution | |
| 10-355436 | In distribution | |
| 3-3839X | In distribution | |
| 3-3834 | In distribution | |
| 3-3798 | In distribution | |
| 3-3805M | In distribution | |
| 4-63300 | In distribution | |
| 85-113 | In distribution | |
| 3-3836CW | In distribution | |
| 4-63030 | In distribution | |
| 4-61510 | In distribution | |
| 3-302 | In distribution | |
| 3-3805WLM | In distribution | |
| 85-115 | In distribution | |
| 4-63820 | In distribution | |
| 1-27809710L | In distribution | |
| 26-13270 | In distribution | |
| 85-3200 | In distribution | |
| 3-3795 | In distribution | |
| 3-3807W | In distribution | |
| 85-112 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.