Intrepid, AutoSert

Intrepid AutoSert IOL Injector

Registry build 21.09.26
1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HQE
Manufacturer City Province Registered as Device types
ABA Medical Technology Co Ltd Guang Dong Guangdong Contract manufacturer 6

Record

Regulatory record for Intrepid, AutoSert
Listed by Alcon Laboratories, Inc., United States
FDA product code HQE
Device type Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device class Class 2
Regulation 21 CFR 886.4150
Record published 2017-06-07
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Latex Labelled latex-free
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Intrepid, AutoSert
Catalogue number Size Status
8065751755 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bausch + Lomb Bausch & Lomb Incorporated 108
Unity Alcon Laboratories, Inc. 47
Synergetics Synergetics USA, Inc. 44
Bi-Blade® Medical Instrument Development Laboratories, Inc. 28
Instrument, Vitreous Aspiration And Cutting, Ac-Powered Medical Instrument Development Laboratories, Inc. 21
Alcon Alcon Laboratories, Inc. 14
Constellation Alcon Laboratories, Inc. 9
Stellaris Bausch & Lomb Incorporated 6
EVA Nexus™ Posterior 25G TDC Pack D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 4
EVA Nexus™ Posterior 23G TDC Pack D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 4
EVA Nexus™ Posterior 27G TDC Pack D.o.r.c. Dutch Ophthalmic Research Center (International) B.V. 4
Engauge, Vektor Alcon Laboratories, Inc. 3

Showing 12 of 65. All products under Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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