Sklar®
Censitrac Ready Sewall Orbital Retr 11MM X50MM
8manufacturers in China registered for this device type
28catalogue 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 | Sklar Corporation, United States |
|---|---|
| FDA product code | HNI |
| Device type | Retractor, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-02-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-1867C | In distribution | |
| 65-1840 | In distribution | |
| 65-1843 | In distribution | |
| 65-1833 | In distribution | |
| 65-1875 | In distribution | |
| 65-1868C | In distribution | |
| 65-1842 | In distribution | |
| 65-1835 | In distribution | |
| 41-1426 | In distribution | |
| 65-1870C | In distribution | |
| 65-1839 | In distribution | |
| 65-1841 | In distribution | |
| 65-1815 | In distribution | |
| 65-1844 | In distribution | |
| 65-1865 | In distribution | |
| 65-1841C | In distribution | |
| 65-1834 | In distribution | |
| 65-1870 | In distribution | |
| 65-1867 | In distribution | |
| 65-1837 | In distribution | |
| 41-1425 | In distribution | |
| 65-1874 | In distribution | |
| 65-1872 | In distribution | |
| 65-1830 | In distribution | |
| 65-1866 | In distribution | |
| 65-1873 | In distribution | |
| 65-1871 | In distribution | |
| 65-1868 | 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 |
| 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 |
| 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.