Sklar
Double spring thumb scissors commonly used in ophthalmic procedures. This product has 6mm, delicate, curved blades.
14manufacturers in China registered for this device type
53catalogue numbers in this listing
1recall
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 | Sklar Corporation, United States |
|---|---|
| FDA product code | HNF |
| Device type | Scissors, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K770040 |
| Record published | 2019-04-04 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 82495 | In distribution | |
| 64-3443 | In distribution | |
| 82530 | In distribution | |
| 64-2242C | In distribution | |
| 82485 | In distribution | |
| 64-1155 | In distribution | |
| 64-1343C | In distribution | |
| 47-1262C | In distribution | |
| 47-1155 | In distribution | |
| 64-2442 | In distribution | |
| 64-2342 | In distribution | |
| 64-1341C | In distribution | |
| 64-2342C | In distribution | |
| 82735 | In distribution | |
| 82465 | In distribution | |
| 65-3448 | In distribution | |
| 64-2442C | In distribution | |
| 82535 | In distribution | |
| 47-1262 | In distribution | |
| 47-1147C | In distribution | |
| 82770 | In distribution | |
| 82480 | In distribution | |
| 82750 | In distribution | |
| 82455 | In distribution | |
| 82470 | In distribution | |
| 64-2242 | In distribution | |
| 64-2245 | In distribution | |
| 82510 | In distribution | |
| 64-3440 | In distribution | |
| 82520 | In distribution | |
| 82730 | In distribution | |
| 64-1340 | In distribution | |
| 64-1343 | In distribution | |
| 82475 | In distribution | |
| 64-2535 | In distribution | |
| 82765 | In distribution | |
| 47-1148 | In distribution | |
| 64-3441 | In distribution | |
| 64-1341 | In distribution | |
| 64-1951 | In distribution | |
| 82540 | In distribution | |
| 82515 | In distribution | |
| 64-3228 | In distribution | |
| 82490 | In distribution | |
| 64-3147 | In distribution | |
| 64-3143 | In distribution | |
| 82525 | In distribution | |
| 64-1260 | In distribution | |
| 64-3442 | In distribution | |
| 47-1147 | In distribution | |
| 64-2535C | In distribution | |
| 82760 | In distribution | |
| 82755 | 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
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 350 units |
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.