Finesse Reflex
27+ Straight Scissors REFLEX DSP
14manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (2), Shandong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Showing 12 of 14. All 14 manufacturers in China registered for Scissors, Ophthalmic
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | HNF |
| Device type | Scissors, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 6 |
| Sizes | Needle gauge 23 to 27 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 805.52 | Needle Gauge 25 G | In distribution |
| 811.53 | Needle Gauge 27 G | In distribution |
| 806.52 | Needle Gauge 23 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 369 |
| Ambler Surgical | Ambler Surgical, LLC | 240 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 191 |
| Millennium | Avalign Technologies, Inc. | 177 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 155 |
| V. Mueller | Steris Corporation | 148 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 124 |
| Stephens Instruments | Krishna Imports Inc | 106 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 103 |
| Pilling | Teleflex Medical LLC | 100 |
| Boss Instruments | Boss Instruments, Ltd. | 82 |
| Ophthalmic Scissors | Katena Products, Inc. | 78 |
Showing 12 of 557. All products under Scissors, Ophthalmic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K873099 | 1987-09-04 |
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.