Oph.Hook
Frederick-Sinskey Hook For Post. Segment
11manufacturers in China registered for this device type
45catalogue numbers in this listing
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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNQ |
| Device type | Hook, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-16 |
| Record revised | 2023-10-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Length 0.15 to 15 mm; lumen/inner diameter 13 to 16 mm; outer diameter 0.15 to 0.18 mm; length 5 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08-04223 | In distribution | |
| 08-13212 | In distribution | |
| 08-13213 | In distribution | |
| 08-04219 | Outer Diameter 0.18 mm | In distribution |
| 08-04203 | In distribution | |
| 05-7001 | In distribution | |
| 08-04234 | Length 0.15 mm | In distribution |
| 08-04221 | Length 15 mm | In distribution |
| 08-07150 | In distribution | |
| 08-04405 | Length 8 mm | In distribution |
| 08-04411 | In distribution | |
| 05-4017 | In distribution | |
| 08-04415 | In distribution | |
| 05-4011 | In distribution | |
| 08-04230 | In distribution | |
| 05-4018 | In distribution | |
| 08-15217 | In distribution | |
| 08-04220 | Outer Diameter 0.18 mm | In distribution |
| 08-04236 | Length 0.15 mm | In distribution |
| 08-13217 | In distribution | |
| 08-04210 | Outer Diameter 0.15 mm | In distribution |
| 08-04233 | Length 0.15 mm | In distribution |
| 08-04225 | In distribution | |
| 05-4012 | In distribution | |
| 05-4070 | Length 0.7 mm | In distribution |
| 08-15221 | Lumen/Inner Diameter 13 mm | In distribution |
| 08-04202 | In distribution | |
| 08-04413 | In distribution | |
| 05-4013 | In distribution | |
| 05-2136B | In distribution | |
| 08-04216 | Length 0.25 mm | In distribution |
| 08-04401 | In distribution | |
| 08-04404 | Length 5 in | In distribution |
| 05-2138 | In distribution | |
| 05-4068 | Length 0.25 mm | In distribution |
| 08-13216 | In distribution | |
| 08-13223 | In distribution | |
| 08-04123 | Length 5 in | In distribution |
| 08-04418 | In distribution | |
| 08-15218 | Lumen/Inner Diameter 13 mm | In distribution |
| 08-15247 | In distribution | |
| 08-04406 | Length 10 mm | In distribution |
| 08-04205 | In distribution | |
| 08-15224 | Lumen/Inner Diameter 13 mm | In distribution |
| 08-15223 | Lumen/Inner Diameter 16 mm | 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
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.