Opthalmic Spatula

Lasik Spatula (Bahamon) Curved 11CM With Semi Sharp Edges

Registry build 21.09.26
9manufacturers in China registered for this device type
50catalogue 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.

Chinese manufacturers registered for FDA product code HND
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

Regulatory record for Opthalmic Spatula
Listed by Ovation International
FDA product code HND
Device type Spatula, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Premarket notification Exempt
Record published 2022-01-21

Specifications

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, manufacturing date

Catalogue Numbers

Catalogue numbers for Opthalmic Spatula
Catalogue number Size Status
OI-2281S-20G In distribution
OI-2284S-20G In distribution
OI-2289T-20G In distribution
OI-2286T-20G In distribution
OI-2285S-20G In distribution
OI-3204T In distribution
OI-2283T-23G In distribution
OI-2287S-20G In distribution
OI-3206S In distribution
OI-3201S In distribution
OI-2284T-20G In distribution
OI-2287T-20G In distribution
OI-2286T-23G In distribution
OI-3203S In distribution
OI-2282T-20G In distribution
OI-2288S-20G In distribution
OI-3204S In distribution
OI-3207T In distribution
OI-2290T-20G In distribution
OI-2283S-23G In distribution
OI-2291S-20G In distribution
OI-2286S-23G In distribution
OC184T In distribution
OC183T In distribution
OI-3208S In distribution
OI-2290S-20G In distribution
OI-3208T In distribution
OC184S In distribution
OI-3202S In distribution
OI-3207S In distribution
OI-2289S-23G In distribution
OI-2281T-20G In distribution
OI-2289S-20G In distribution
OI-3205S In distribution
OI-3203T In distribution
OI-2283T-20G In distribution
OI-3206T In distribution
OI-2286S-20G In distribution
OI-3201T In distribution
OI-2291T-20G In distribution
OI-2289S-25G In distribution
OI-3205T In distribution
OI-3202T In distribution
OC183S In distribution
OI-2282S-20G In distribution
OI-2288T-20G In distribution
OI-2285T-20G In distribution
OI-2289T-25G In distribution
OI-2289T-23G In distribution
OI-2283S-20G In distribution

Same Product Code

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer