Sklar
Censitrac Ready Kuglen Iris Hook Manip Clovlef
11manufacturers in China registered for this device type
66catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| 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 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Guangzhou Kaiheng K&S Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HNQ |
| Device type | Hook, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-21 |
| Record revised | 2021-06-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66-8327 | In distribution | |
| 82205 | In distribution | |
| 66-7720 | In distribution | |
| 65-3215C | In distribution | |
| 65-3209 | In distribution | |
| 65-3211 | In distribution | |
| 65-3218 | In distribution | |
| 65-3208 | In distribution | |
| 65-3201 | In distribution | |
| 65-3191 | In distribution | |
| 66-7710 | In distribution | |
| 66-8332 | In distribution | |
| 65-9085 | In distribution | |
| 65-3225 | In distribution | |
| 65-3205 | In distribution | |
| 66-7706 | In distribution | |
| 65-3206 | In distribution | |
| 65-3248 | In distribution | |
| 66-7727 | In distribution | |
| 66-8328 | In distribution | |
| 65-3267 | In distribution | |
| 65-3217 | In distribution | |
| 65-3236 | In distribution | |
| 66-8330 | In distribution | |
| 82125 | In distribution | |
| 65-3219 | In distribution | |
| 66-7712 | In distribution | |
| 65-3201C | In distribution | |
| 65-3200 | In distribution | |
| 65-3214 | In distribution | |
| 65-3200C | In distribution | |
| 66-7735 | In distribution | |
| 66-7727C | In distribution | |
| 82185 | In distribution | |
| 82200 | In distribution | |
| 65-3202 | In distribution | |
| 82120 | In distribution | |
| 66-7726 | In distribution | |
| 66-7755 | In distribution | |
| 06-4174 | In distribution | |
| 66-7785 | In distribution | |
| 82195 | In distribution | |
| 65-3191C | In distribution | |
| 65-3251 | In distribution | |
| 65-3250 | In distribution | |
| 65-3210 | In distribution | |
| 65-3195 | In distribution | |
| 06-4171 | In distribution | |
| 65-3217C | In distribution | |
| 82155 | In distribution | |
| 66-7725 | In distribution | |
| 65-3265 | In distribution | |
| 65-3235 | In distribution | |
| 82130 | In distribution | |
| 66-7786 | In distribution | |
| 06-4173 | In distribution | |
| 06-4170 | In distribution | |
| 66-7756 | In distribution | |
| 66-7705 | In distribution | |
| 65-3207 | In distribution | |
| 65-3203 | In distribution | |
| 66-8333 | In distribution | |
| 65-3216 | In distribution | |
| 65-3216C | In distribution | |
| 65-3215 | In distribution | |
| 66-7775 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Walcott Rx Products | Walcott Rx Product Inc | 511 |
| Ambler Surgical | Ambler Surgical, LLC | 416 |
| MR Phaco | Crestpoint Management Ltd. | 403 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 385 |
| Millennium | Avalign Technologies, Inc. | 244 |
| Stephens Instruments | Krishna Imports Inc | 98 |
| Diamatrix | Diamatrix | 89 |
| Duckworth & Kent | Duckworth AND Kent Limited | 85 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 81 |
| Rumex | Rumex International Co. | 77 |
| Ophthalmic Hook | Katena Products, Inc. | 74 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 74 |
Showing 12 of 534. All products under Hook, 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. | 25 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.