Ambler Surgical
Iris retractors, round, bright blue, flexible polypropylene fiber, 1 set of 6 retractors, supplied non-sterile in a steam autoclavable container, not recommended for more then 3 uses
8manufacturers in China registered for this device type
55catalogue 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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HNI |
| Device type | Retractor, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
| Record revised | 2022-08-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Jaeger lid plate | In distribution | |
| Wills Eye lacrimal sac retractors | In distribution | |
| Jaffe wire lid retractors | In distribution | |
| Orbital retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Stevenson lacrimal sac self-retaining retractor | In distribution | |
| Chedly lid retractor | In distribution | |
| Ferris-Smith-Sewall orbital retractor | In distribution | |
| Tennant lid retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Jaffe wire lid retractors | In distribution | |
| Schepens orbital retractor | In distribution | |
| Mackool capsule retractor | In distribution | |
| Yancoskie coronal left retractor | In distribution | |
| Jaffe wire lid retractors | In distribution | |
| Schepens orbital retractor | In distribution | |
| Osher iris retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Iris retractors | In distribution | |
| Iris retractors | In distribution | |
| Orbital retractor | In distribution | |
| Helveston ”Big Barbie” tissue retractor | In distribution | |
| Ferris-Smith-Sewall orbital retractor | In distribution | |
| Schepens orbital retractor | In distribution | |
| Iris retractors | In distribution | |
| Rizzuti expressor/iris retractor | In distribution | |
| Ferris-Smith-Sewall orbital retractor | In distribution | |
| Agricola lacrimal sac retractor | In distribution | |
| Schocket scleral depressor | In distribution | |
| Stevenson lacrimal sac retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Sewall orbital retractor | In distribution | |
| Sewall orbital retractor | In distribution | |
| Helveston ”Barbie” tissue retractor | In distribution | |
| Fisher lid retractor | In distribution | |
| Iris retractors | In distribution | |
| Desmarres lid retractor | In distribution | |
| Sewall orbital retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Mann-Hunkeler capsule retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Berke-Jaeger lid plate | In distribution | |
| Desmarres lid retractor | In distribution | |
| Jaeger lid plate | In distribution | |
| Desmarres lid retractor | In distribution | |
| Helveston ”Great Big Barbie” tissue retractor | In distribution | |
| Desmarres lid retractor | In distribution | |
| Conway lid retractor | In distribution | |
| Arruga retractor | In distribution | |
| McCapherty pusher | In distribution | |
| Desmarres lid retractor | In distribution | |
| Sewall orbital retractor | In distribution | |
| Iris retractors | In distribution | |
| de-Juan conjunctival retractor | In distribution | |
| Desmarres lid retractor | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 70 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 59 |
| 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 |
| 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.