MR Phaco

Carones LASEK Spatula DBL-Ended, LARGE Spatula, The Arc of the spatula represents a 30 Degree section of a 9mm optical zone, Angled 4mm from bend to tip, / SMALL Spatula, The Arc of the…

Registry build 21.09.26

Carones LASEK Spatula DBL-Ended, LARGE Spatula, The Arc of the spatula represents a 30 Degree section of a 9mm optical zone, Angled 4mm from bend to tip, / SMALL Spatula, The Arc of the spatula represents a 30 Degree section of a 7mm optical zone, Angled 3mm from bend to tip, Round Knurled Handle, 126mm Overall Length, Stainless Steel

9manufacturers in China registered for this device type
85catalogue 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 MR Phaco
Listed by Crestpoint Management Ltd., 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 2025-06-07

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for MR Phaco
Catalogue number Size Status
PH6572 In distribution
PH6146 In distribution
PH4286 In distribution
PH1805T In distribution
PH6006M In distribution
PH6006 In distribution
PH6116 In distribution
PH1920T In distribution
PH6152 In distribution
PH1855 In distribution
PH1800T In distribution
H1855 In distribution
PH1954 In distribution
PH6646 In distribution
MMP256T In distribution
PH1865 In distribution
PH6573T In distribution
PH6669 In distribution
H1805 In distribution
PH6574 In distribution
PH6566 In distribution
PH6277-1 In distribution
PH6397 In distribution
PH1754-1 In distribution
PH1856 In distribution
PH6114 In distribution
PH6115 In distribution
PH1805 In distribution
PH1885 In distribution
MMP256 In distribution
PH6565 In distribution
PH6118 In distribution
PH6153 In distribution
PH1915 In distribution
PH1855T In distribution
PH6277 In distribution
PH1868 In distribution
PH6276T In distribution
PH1754N-1 In distribution
PH1866 In distribution
PH6142 In distribution
PH1754 In distribution
PH6289 In distribution
H2005-1 In distribution
PH6502 In distribution
PH6723 In distribution
PH1886 In distribution
PH1800 In distribution
PH6001 In distribution
PH1920 In distribution
PH6125 In distribution
PH6572T In distribution
PH1900T In distribution
PH6276 In distribution
H2005 In distribution
PH1867 In distribution
PH1806T In distribution
PH6645 In distribution
PH6649 In distribution
PH6124 In distribution
PH6139 In distribution
PH6117 In distribution
PH1900 In distribution
PH6128 In distribution
PH1864 In distribution
PH1806 In distribution
PH6573 In distribution
PH6136 In distribution
PH1884 In distribution
PH6356 In distribution
PH6376 In distribution
PH6668 In distribution
PH6356T In distribution
H2005-2 In distribution
PH6703 In distribution
PH6612 In distribution
PH6205 In distribution
PH6594 In distribution
PH6607 In distribution
PH6141 In distribution
PH6143 In distribution
PH1754N In distribution
PH1945 In distribution
PH6594T In distribution
PH6591 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
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.

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