Ophthalmic Retractor
Helveston "great BIG Barbie" Retractor 11MM
8manufacturers in China registered for this device type
18catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNI |
| Device type | Retractor, 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 | 2020-09-14 |
| Record revised | 2022-12-15 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Sizes | Width 7 to 17 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K1-8000 | In distribution | |
| K1-9019 | Width 11 mm | In distribution |
| K1-8220 | Width 15 mm | In distribution |
| K1-8230 | Size 3 | In distribution |
| K1-8520 | In distribution | |
| K1-9550 | In distribution | |
| K1-9520 | In distribution | |
| K1-9012 | Width 9 mm | In distribution |
| K1-9008 | In distribution | |
| K1-8200 | Size 0 | In distribution |
| K1-9000 | In distribution | |
| K1-9001 | In distribution | |
| K1-9010 | Width 7 mm | In distribution |
| K1-8500 | In distribution | |
| K1-8210 | Size 1 | In distribution |
| K1-7880 | In distribution | |
| K1-9500 | In distribution | |
| K1-8001 | In distribution |
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 |
| Retractor | KLS-Martin L.P. | 27 |
| 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 |
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.