Retractor
Knapp, Rollet, Sharp, Flexible, 4 Prong
8manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| 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 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | HNI |
| Device type | Retractor, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2024-08-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15-091-10-07 | 16 CM | In distribution |
| 34-731-14-07 | 14 CM | In distribution |
| 34-278-13-07 | 14.5 CM | In distribution |
| 34-296-11-93 | 11 CM | In distribution |
| 01-091-10-07 | 16 CM | In distribution |
| 34-277-13-07 | 14.5 CM | In distribution |
| 15-091-08-07 | 16 CM | In distribution |
| 34-724-13-07 | 13 CM | In distribution |
| 34-296-11-01 | 11 CM | In distribution |
| 34-730-14-07 | 13 CM | In distribution |
| 15-091-14-07 | 16 CM | In distribution |
| 34-273-13-07 | 14 CM | In distribution |
| 15-091-16-07 | 16 CM | In distribution |
| 34-728-14-07 | 14 CM | In distribution |
| 01-091-12-07 | 16 CM | In distribution |
| 01-091-16-07 | 16 CM | In distribution |
| 15-091-18-07 | 16 CM | In distribution |
| 34-729-14-07 | 14 CM | In distribution |
| 34-275-13-07 | 14 CM | In distribution |
| 15-091-12-07 | 16 CM | In distribution |
| 34-722-13-07 | 13 CM | In distribution |
| 34-271-13-07 | 13.5 CM | In distribution |
| 34-711-13-07 | 13 CM | In distribution |
| 34-716-13-07 | 13 CM | In distribution |
| 34-276-13-07 | 14.5 CM | In distribution |
| 01-091-18-07 | In distribution | |
| 01-275-13-07 | 13 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 70 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 59 |
| Ambler Surgical | Ambler Surgical, LLC | 55 |
| Duckworth & Kent | Duckworth AND Kent Limited | 54 |
| V. Mueller | Steris Corporation | 43 |
| Sklar® | Sklar Corporation | 28 |
| Desmarres LID Retractor | Sontec Instruments, Inc. | 26 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 26 |
| Pilling | Teleflex Medical LLC | 25 |
| Aesculap | Aesculap AG | 24 |
| Stephens Instruments | Krishna Imports Inc | 21 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 20 |
Showing 12 of 120. All products under Retractor, 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.