PRK, LASIK, Lasek, IntraLasik and Flap Management Instruments
MacRae Flap Flipper, DBL-Ended, Spatula is .9mm wide, Angled 10mm from bend to tip / V-shaped tip .8mm wide Angled 9.5mm from bend to tip with sharp inner edges, Round Knurled Handle, 132mm…
MacRae Flap Flipper, DBL-Ended, Spatula is.9mm wide, Angled 10mm from bend to tip / V-shaped tip.8mm wide Angled 9.5mm from bend to tip with sharp inner edges, Round Knurled Handle, 132mm Overall Length, Stainless Steel
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Ophsurin Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 6 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Aurora Surgical, LLC, United States |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AS3-632 | In distribution | |
| AS3-609 | In distribution | |
| AS3-631 | In distribution | |
| AS3-620 | In distribution | |
| AS3-610 | In distribution | |
| AS3-608 | In distribution | |
| AS3-611 | In distribution | |
| AS3-630 | In distribution | |
| AS3-612 | In distribution | |
| AS3-624T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 209 |
| Surgical Direct | Surgical Direct, Inc. | 201 |
| Ambler Surgical | Ambler Surgical, LLC | 164 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 155 |
| Oph.Spatula | Katena Products, Inc. | 132 |
| Ophthalmic Spatula | Katena Products, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 103 |
| MR Phaco | Crestpoint Management Ltd. | 85 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 83 |
| Sklar® | Sklar Corporation | 62 |
| Stephens Instruments | Krishna Imports Inc | 60 |
| Rumex | Rumex International Co. | 54 |
Showing 12 of 401. All products under Spatula, 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.