MR Phaco

Koch Mendez Fixation Ring, Beveled Degree Gauge with teeth, Handle Mounted at 135 Degrees, Works well with our CM-0402, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree…

Registry build 21.09.26

Koch Mendez Fixation Ring, Beveled Degree Gauge with teeth, Handle Mounted at 135 Degrees, Works well with our CM-0402, 5 Degree Ruler markings on top of Unique bevel (labeled at 30 Degree increments), Round Knurled Handle, Titanium (with Stainless color)

8manufacturers in China registered for this device type
55catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (1), Guangdong (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 HOE
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Providence Enterprise Limited Shenzhen Guangdong Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
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
Huaian Frimen Co., Ltd. Huaian Jiangsu Manufacturer 16

Record

Regulatory record for MR Phaco
Listed by Crestpoint Management Ltd., United States
FDA product code HOE
Device type Caliper, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2025-05-27
Record revised 2025-06-10 (version 2)

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
Distribution end date 2025-05-27

Catalogue Numbers

Catalogue numbers for MR Phaco
Catalogue number Size Status
PH6127 In distribution
PH9521 In distribution
PH9400T In distribution
PH9407T In distribution
PH6434R In distribution
PH6256 In distribution
PH9403 In distribution
PH6251 In distribution
PH9511 In distribution
PH9522T In distribution
PH6252 In distribution
PH9510 In distribution
PH9400 In distribution
PH9520T In distribution
PH9404 In distribution
PH9508 In distribution
PH9522 In distribution
PH6255 In distribution
PH9403T In distribution
PH9401 In distribution
PH6581-1 In distribution
PH2004 In distribution
PH94071T In distribution
PH9361 In distribution
PH9402 In distribution
PH9405 In distribution
PH9405T In distribution
PH6584-1 In distribution
PH9509 In distribution
PH6583 In distribution
PH9521T In distribution
PH6434L In distribution
PH9509T In distribution
PH6580 In distribution
PH6581 In distribution
PH9408T In distribution
PH6584 In distribution
PH6254 In distribution
PH9361-T In distribution
PH9409T In distribution
PH6433R In distribution
PH6439 In distribution
PH9362 In distribution
PH6433L In distribution
PH6250 In distribution
PH6582 In distribution
PH6435 In distribution
PH6436 In distribution
PH9362T In distribution
PH2033 In distribution
PH9512 In distribution
PH9408 Withdrawn
PH9403 Withdrawn
PH6253 Withdrawn
PH94071T Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ambler Surgical Ambler Surgical, LLC 20
Millennium Avalign Technologies, Inc. 17
Duckworth & Kent Duckworth AND Kent Limited 15
Castroviejo Caliper Sontec Instruments, Inc. 11
gSource Gsource, LLC. 10
Ophthalmic Caliper Katena Products, Inc. 10
MSI Precision Specialty Instruments MED Saver, Inc. 9
Walcott Rx Products Walcott Rx Product Inc 8
Caliper, Ophthalmic Black & Black Surgical, Inc. 8
Boss Instruments Boss Instruments, Ltd. 8
V. Mueller Steris Corporation 7
Epsilon USA Epsilon EYE Care PVT., Ltd. 7

Showing 12 of 108. All products under Caliper, 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