Epsilon USA

Ogawa AC Maintainer Cannula 21G - 4.5mm Long Ogawa AC Maintainer Cannula 22G - 4.5mm Long Ogawa AC Maintainer Cannula 23G - 4.5mm Long

Registry build 21.09.26
6manufacturers in China registered for this device type
51catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HMX
Manufacturer City Province Registered as Device types
Malosa Medical Instruments (Changshu) Limited Changshu Jiangsu Contract manufacturer 24
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Asol Co., Ltd. Huaian Jiangsu Manufacturer 22
Belle Healthcare Technology Co., Ltd. Suzhou Jiangsu Manufacturer 20
Huaian Frimen Co., Ltd. Huaian Jiangsu Manufacturer 16

Record

Regulatory record for Epsilon USA
Listed by Epsilon EYE Care PVT., Ltd., India
FDA product code HMX
Device type Cannula, Ophthalmic
Device class Class 1
Regulation 21 CFR 886.4350
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-01-06

Specifications

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

Catalogue Numbers

Catalogue numbers for Epsilon USA
Catalogue number Size Status
EEC-178 In distribution
EEC-135 In distribution
EEC-019 In distribution
EEC-179 In distribution
EEC-174 In distribution
EEC-011 In distribution
EEC-114 In distribution
EEC-160 In distribution
EEC-184 In distribution
EEC-033 In distribution
EEC-006 In distribution
EEC-048 In distribution
EB-03AS In distribution
EEC-074 In distribution
EEC-061 In distribution
EEC-008 In distribution
EEC-200 In distribution
EEC-072 In distribution
EEC-071 In distribution
EEC-009 In distribution
EEC-185 In distribution
EEC-181 In distribution
EEC-168 In distribution
EEC-171 In distribution
EEC-002 In distribution
CA-605 In distribution
EEC-059 In distribution
EEC-004 In distribution
EEC-115 In distribution
EEC-089 In distribution
EEC-005 In distribution
EEC-137 In distribution
EEC-172 In distribution
EEC-007 In distribution
EEC-136 In distribution
EEC-116 In distribution
EEC-070 In distribution
EEC-049 In distribution
EEC-003 In distribution
EEC-104 In distribution
EEC-173 In distribution
EEC-078 In distribution
EEC-025 In distribution
EEC-010 In distribution
EB-23A In distribution
EEC-001 In distribution
EEC-170 In distribution
EEC-088 In distribution
EEC-073 In distribution
EEC-177 In distribution
EEC-186 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Anodyne Surgical Psi/Eye-Ko, Inc. 909
Walcott Rx Products Walcott Rx Product Inc 663
MR Phaco Crestpoint Management Ltd. 625
MSI Precision Specialty Instruments MED Saver, Inc. 511
Ambler Surgical Ambler Surgical, LLC 447
Millennium Avalign Technologies, Inc. 270
Ophthalmic Cannula Katena Products, Inc. 251
Surgistar Surgistar, Inc. 179
Bausch + Lomb Bausch & Lomb Incorporated 137
Walcott Rx Products Psi/Eye-Ko, Inc. 133
Surgical Direct Surgical Direct, Inc. 127
Visitec® Beaver-Visitec International, Ltd 124

Showing 12 of 1,064. All products under Cannula, 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