Sklar Instruments
Econo Sterile Iris Hook QK REL 4MM 9" STER25
11manufacturers in China registered for this device type
1catalogue number
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 | 2025-01-03 |
| Record revised | 2025-02-12 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 96-2224A | 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sklar Corporation | UDI-DI | 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.