Ambler Surgical
Fukasaku phaco chopper & Lieberman phaco spatula, 5 1/2'', double-ended, angled shafts, 10.0mm from bend to tip, wedge-shaped flat interior cutting edge, blunt tip, with notch for engaging…
Fukasaku phaco chopper & Lieberman phaco spatula, 5 1/2”, double-ended, angled shafts, 10.0mm from bend to tip, wedge-shaped flat interior cutting edge, blunt tip, with notch for engaging the iris, microfinger chopper, blunt tip, for use in the right hand, round handle
9manufacturers in China registered for this device type
164catalogue numbers in this listing
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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HND |
| Device type | Spatula, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
| Record revised | 2021-06-08 (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 |
| Packaging | Box of 3, box of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Espiritu-Caparas nucleus chopper & spatula | In distribution | |
| Jaffe lens spatula | In distribution | |
| Lieberman microfinger & spatula | In distribution | |
| Buratto LASIK flap protector | In distribution | |
| Melles PLK scraper | In distribution | |
| MacRae LASIK flap flipper | In distribution | |
| Mannis-Buratto LASIK flap protector | In distribution | |
| Rake membrane spatula | In distribution | |
| Cleasby iris spatula | In distribution | |
| Rainin lens spatula | In distribution | |
| Girard synechiae spatula | In distribution | |
| Slade refractive flap spatula | In distribution | |
| Kansas nucleus support spatula | In distribution | |
| Rowen phaco spatula | In distribution | |
| Machat Intralase spatula | In distribution | |
| Eippert femtosecond incision spatula | In distribution | |
| Terry DSEK scraper | In distribution | |
| Slade femtosecond laser spatula | In distribution | |
| Kansas nucleus support spatula | In distribution | |
| Fukasaku phaco chopper & Lieberman phaco spatula | In distribution | |
| Thorlakson LASIK flap lifter | In distribution | |
| Femtosecond incision spatula | In distribution | |
| Barraquer iris spatula | In distribution | |
| Kimura platinum spatula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Modified Machat corneal LASIK spatula | In distribution | |
| Niksarli II IntraLase flap lifter/retreatment spatula | In distribution | |
| Machat LASIK retreatment spatula | In distribution | |
| Koch-Nagahara spatula & chopper | In distribution | |
| Maumenee-Barraquer vitreous sweep – right | In distribution | |
| Folden femtosecond incision spatula/dissector | In distribution | |
| Fukasaku LASIK spatula | In distribution | |
| Gulani interface spatula | In distribution | |
| Hirschman iris lens spatula | In distribution | |
| Mackool enhanced combo chopper/spatula | In distribution | |
| Carones LASEK spatula | In distribution | |
| Slade femtosecond laser spatula | In distribution | |
| John DXEK/DSAEK descemet’s stripper | In distribution | |
| Barraquer iris spatula | In distribution | |
| Sloane LASEK micro hoe/epi peeler | In distribution | |
| Machat LASIK retreatment spatula | In distribution | |
| Vidaurri LASIK retreatment spatula | In distribution | |
| Fukasaku phaco chopper & Lieberman phaco spatula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Knolle lens nucleus spatula and anterior chamber gauge | In distribution | |
| Nagahara nucleus spatula | In distribution | |
| Koch-Nagahara spatula & karate chopper | In distribution | |
| Seibel I IntraLase flap lifter/retreatment spatula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Lieppman nucleus spatula | In distribution | |
| Barraquer iris spatula | In distribution | |
| DSAEK descemet’s membrane stripper | In distribution | |
| DSAEK descemet’s membrane stripper | In distribution | |
| Melles PLK scraper | In distribution | |
| Friedman-Koch phaco chopper/spatula | In distribution | |
| Culler iris spatula | In distribution | |
| Femtosecond incision spatula | In distribution | |
| Olk retinal spatula | In distribution | |
| Modified Machat corneal LASIK spatula | In distribution | |
| Simcoe nucleus spatula cannula | In distribution | |
| John Dexatome DMEK/DSAEK spatula | In distribution | |
| John DXEK/DSAEK stromal scrubber | In distribution | |
| Sloane LASEK micro hoe | In distribution | |
| Sarnicola DALK big bubble spatula | In distribution | |
| Seibel I IntraLase flap lifter/retreatment spatula | In distribution | |
| Maddox LASIK spatula | In distribution | |
| Kansas nucleotome bisection spatula | In distribution | |
| Johnson spatula | In distribution | |
| Nichamin nucleus chopper & spatula | In distribution | |
| Randolph cyclodialysis cannula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Mackool enhanced combo chopper/spatula | In distribution | |
| Sheets cyclodialysis cannula | In distribution | |
| Ambler endothelial stripper | In distribution | |
| Koch nucleus spatula | In distribution | |
| Culler iris spatula | In distribution | |
| Machat LASIK retreatment spatula | In distribution | |
| DSAEK descemet’s membrane stripper | In distribution | |
| Bonfadini DALK spatula | In distribution | |
| Terry DSAEK scraper | In distribution | |
| Nagahara phaco chopper/Drysdale nucleus manipulator | In distribution | |
| Terry DSEK scraper | In distribution | |
| Wheeler/Elschnig cyclodialysis spatula | In distribution | |
| Koch-Nagahara spatula & chopper | In distribution | |
| Mackool chopper/spatula | In distribution | |
| Randolph cyclodialysis cannula | In distribution | |
| Clayman nucleus spatula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Lieberman microfinger & spatula | In distribution | |
| Masket phaco spatula | In distribution | |
| Machat Intralase spatula | In distribution | |
| Donnenfeld femtosecond spatula | In distribution | |
| DSAEK descemet’s membrane stripper | In distribution | |
| Masket phaco spatula | In distribution | |
| Elschnig cyclodialysis spatula | In distribution | |
| Busin DSAEK glide spatula | In distribution | |
| Obstbaum synechiae spatula | In distribution | |
| Gans cyclodialysis cannula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Hersh IntraLase flap spatula | In distribution | |
| Wheeler iris/cyclodialysis spatula | In distribution | |
| Kelman cyclodialysis cannula | In distribution | |
| Olk retinal spatula | In distribution | |
| Barraquer iris spatula | In distribution | |
| Machat LASIK retreatment spatula | In distribution | |
| Cokingtin LRI flap spatula | In distribution | |
| Machat PRK/LASIK spatula | In distribution | |
| Guimaraes LASIK spatula | In distribution | |
| Gimbel nucleus spatula | In distribution | |
| McReynolds spatula/hook | In distribution | |
| Moran LASIK enhancement spatula | In distribution | |
| Koch-Nagahara spatula & karate chopper | In distribution | |
| Sales DSAEK stripper paddle | In distribution | |
| DSAEK descemet’s membrane stripper | In distribution | |
| Kimura platinum spatula | In distribution | |
| Banaji LASIK spatula | In distribution | |
| Koch phaco spatula | In distribution | |
| Koch nucleus spatula | In distribution | |
| Fogla DALK spatula | In distribution | |
| Machat Intralase spatula | In distribution | |
| Maloney PRK spatula | In distribution | |
| Y-hook manipulator and spatula | In distribution | |
| Lane femtosecond cataract incision spatula | In distribution | |
| Lambert rake membrane spatula | In distribution | |
| Johnson spatula | In distribution | |
| Buratto LASIK flap protector | In distribution | |
| Benedetto Intralase spatula | In distribution | |
| Rowen phaco spatula | In distribution | |
| Maddox LASIK spatula | In distribution | |
| Barraquer iris spatula | In distribution | |
| Eppert femtosecond incision spatula | In distribution | |
| Castroviejo cyclodialysis spatula | In distribution | |
| Knolle nucleus spatula | In distribution | |
| Barraquer cyclodialysis spatula | In distribution | |
| Slade LASIK retreatment spatula | In distribution | |
| Castroviejo synechiae spatula | In distribution | |
| Rosenwasser endothelial stripper | In distribution | |
| Cindy DSAEK sweeper | In distribution | |
| Ambler SMILE dissection spatula | In distribution | |
| Barraquer iris spatula | In distribution | |
| Koch phaco spatula | In distribution | |
| Pearce spatula | In distribution | |
| John ALK Pre-Descemet membrane spatula | In distribution | |
| Maumenee-Barraquer vitreous sweep – left | In distribution | |
| Rossenwasser DSEAK donor lamella inserting shovel | In distribution | |
| Nagahara phaco chopper/Drysdale nucleus manipulator | In distribution | |
| Nordan capsule elevator | In distribution | |
| Rowen LASIK flap protector/spatula | In distribution | |
| Lege-Seibel IntraLase flap lifter/retreatment spatula | In distribution | |
| Yeoh femtosecond incision spatula | In distribution | |
| Randolph cyclodialysis cannula | In distribution | |
| Seibel LASIK flap lifter/spatula | In distribution | |
| DSAEK descemet’s membrane stripper | In distribution | |
| Jaffe lens spatula | In distribution | |
| Starlite MICS Castroviejo cyclodialysis spatula | In distribution | |
| Kelman cyclodialysis cannula | In distribution | |
| MacRae LASIK/Femtosecond laser spatula | In distribution | |
| McPherson iris spatula | In distribution | |
| Lieberman microfinger & spatula | In distribution | |
| Femtosecond incision spatula | In distribution | |
| Mackool chopper/spatula | In distribution | |
| Sinskey nucleus spatula | In distribution | |
| Castroviejo synechiae spatula | In distribution | |
| Olk retinal spatula | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epsilon USA | Epsilon EYE Care PVT., Ltd. | 209 |
| Surgical Direct | Surgical Direct, Inc. | 201 |
| 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 |
| Opthalmic Spatula | Ovation International | 50 |
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.