23ga Edge Advantage ILM Elevator
23ga ILM elevator
11manufacturers in China registered for this device type
1catalogue number
2recalls on this code
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 | Vortex Surgical, 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 | 2016-11-30 |
| Record revised | 2022-11-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Packaging | Pack of 5 |
| Sizes | Needle gauge 23 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VS0300.23 | Needle Gauge 23 G | 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
2 of these are 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 |
|---|---|---|---|---|
| 2025-12-16 | Class II | Employee error | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. | 14,789 (8651 US; 6138 OUS) |
| 2025-12-16 | Class II | Employee error | There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection. | 14,789 (8651 US; 6138 OUS) |
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.