Home GUDID 00888937004083 Frigitronics
Primary DI 00888937004083
Brand Frigitronics
Company Coopersurgical, Inc.
Model 163
Device description Supercool Retinal, Spherical Probe. Tip Sphere: 3.0mm diameter. Shaft: 28mm length x 2.1mm diameter.
Published 2016-07-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00888937004083 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 00888937004083 00888937004083 888937004083 0888937004083
GMDN Terms# Term, Definition table Term Definition Ophthalmic cryosurgical system applicator, retinal A hand-held device that is a component of an electronic ophthalmic cryosurgical system designed for the application of cold, produced by a cryogen from a cylinder connected via the system control unit, to retinal tissue for various therapeutic applications (e.g., to treat retinal tears and detachments) during ophthalmic surgery. It is typically formed as a handpiece with an insulated grip and attached tubing with connector for attachment to the control unit, and is available with a variety of tip configurations (e.g., curved, midreach, right angle, extended reach). This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Ethylene Oxide;Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 801895244 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10817489026615 23ga MultiFlex™ Extendable Laser Probe, Iridex Connector KATALYST SURGICAL LLC HQA 2017-12-17 00888937019896 Trichiasis Coopersurgical, Inc. HQA 2017-09-27 00888937009422 Frigitronics Coopersurgical, Inc. HQA 2016-08-02 00888937004052 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004069 Frigitronics Coopersurgical, Inc. HQA 2016-07-20 00888937004076 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 00888937004328 Frigitronics Coopersurgical, Inc. HQA 2016-07-20