Home GUDID 08800073100124 OcuCool
Primary DI 08800073100124
Brand OcuCool
Company RecensMedical, Inc.
Model ODM-E01
Device description OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera.
Published 2026-05-19
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 QZQ Ophthalmic Cooling Anesthesia Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QZQ Ophthalmic Cooling Anesthesia Device
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800073100124 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800073100124 08800073100124 8800073100124
GMDN Terms# Term, Definition table Term Definition Ophthalmic injector/illuminating catheter A non-electric, hand-held, fibreoptic, device intended for controlled manual intraocular infusion of a fluid (e.g., viscoelastic substance), while facilitating illumination of the interior of the eye, during an ophthalmic surgical procedure (e.g., viscodilation of Schlemm’s canal). It includes a very thin and flexible tube (microcatheter) with an incorporated fibreoptic bundle and a manual fluid injector; it is designed for connection to a light source (not included). This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 694808508 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company#