Aesculap
SEWALL Wound Retractor (With Blade), 6 1/2", (160 mm), 11 x 50 mm, non-sterile, reusable
8manufacturers in China registered for this device type
24catalogue 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 | Aesculap AG, Germany |
|---|---|
| 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-25 |
| Record revised | 2021-12-14 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MA731R | In distribution | |
| MA425R | In distribution | |
| MA749R | In distribution | |
| MA755R | In distribution | |
| MA436R | In distribution | |
| MA764R | In distribution | |
| MA752R | In distribution | |
| MA290R | In distribution | |
| MA765 | In distribution | |
| MA744R | In distribution | |
| MA757R | In distribution | |
| MA762R | In distribution | |
| MA759R | In distribution | |
| MA751R | In distribution | |
| MA434R | In distribution | |
| MA435R | In distribution | |
| MA750R | In distribution | |
| MA745R | In distribution | |
| MA756R | In distribution | |
| MA758R | In distribution | |
| MA437R | In distribution | |
| MA760R | In distribution | |
| MA754R | In distribution | |
| MA763R | 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 |
| 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.