Home GUDID 00888937009422 Frigitronics
Primary DI 00888937009422
Brand Frigitronics
Company Coopersurgical, Inc.
Model CE-2000
Device description Cryosurgical System
Published 2016-08-02
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HQA Unit, Cryotherapy, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HQA Unit, Cryotherapy, Ophthalmic Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00888937009422 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00888937009422 00888937009422 888937009422 0888937009422
GMDN Terms# Term, Definition table Term Definition Ophthalmic cryosurgical system, electronic An assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal during an ophthalmic surgical procedure. The system typically includes an electronic control unit which controls the flow of cryogen contained in a connected cylinder, dedicated cryogen-cooled hand-held applicators (probes) to apply the cold to the tissue, a foot-switch, and interconnections. It is commonly used for cryopexy for retinal detachment, cataract extraction, and to treat glaucoma, trichiasis, and retinopathy of prematurity (ROP).
Regulatory Flags# DUNS number 801895244 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10840096211426 23ga Multi-Flex™ Extendable Laser Probe, Quantel Connector KATALYST SURGICAL LLC HQA 2020-03-25 10817489026615 23ga MultiFlex™ Extendable Laser Probe, Iridex Connector KATALYST SURGICAL LLC HQA 2017-12-17 00888937019896 Trichiasis Coopersurgical, Inc. HQA 2017-09-27 00888937004052 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004069 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004076 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004083 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004090 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004106 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004113 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004120 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004137 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004144 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004151 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004168 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004175 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004182 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004199 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004205 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004212 Frigitronincs Coopersurgical, Inc. HQA 2016-07-20 00888937004229 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004236 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004243 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004250 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004267 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004274 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004281 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004298 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004304 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004311 Frigitronics Coopersurgical, Inc. HQA 2016-07-20