Phaco Choppers

Chaya Double Ended Chopper, Triple Edged Chopper With Polisher Tip (Verges Style)/Modified Axe Chopper, Offset at 90 Degree, LHD

Registry build 21.09.26
9manufacturers in China registered for this device type
45catalogue 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 Phaco Choppers
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 2023-07-10

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization

Catalogue Numbers

Catalogue numbers for Phaco Choppers
Catalogue number Size Status
AS9-044 In distribution
AS9-028 In distribution
AS9-030LT In distribution
AS9-027L In distribution
AS9-049L In distribution
AS9-041 In distribution
AS9-047 In distribution
AS9-035T In distribution
AS9-052L In distribution
AS9-034T In distribution
AS9-034T-SP In distribution
AS9-049R In distribution
AS9-028T In distribution
AS9-040R In distribution
AS9-031T In distribution
AS9-036R In distribution
AS9-052R In distribution
AS9-029L In distribution
AS9-032T In distribution
AS9-030RT In distribution
AS9-033 In distribution
AS50-9038S In distribution
AS9-030R In distribution
AS9-050 In distribution
AS9-048 In distribution
AS9-032 In distribution
AS9-029R In distribution
AS9-045 In distribution
AS9-040L In distribution
AS9-037R In distribution
AS50-9036RS In distribution
AS9-036L In distribution
AS9-027R In distribution
AS9-029LT In distribution
AS9-051 In distribution
AS9-030L In distribution
AS9-042 In distribution
AS9-029RT In distribution
AS50-9031S In distribution
AS9-035 In distribution
AS9-038 In distribution
AS9-034S In distribution
AS9-039 In distribution
AS9-046 In distribution
AS9-031 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