Home GUDID G16010440021 EverPatch+
Primary DI G16010440021
Brand EverPatch+
Company CORNEAT VISION LTD
Model 1044002
Catalog number 1044002
Device description Permanent Scleral Reinforcement Matrix. Two shapes (one rectangular, one shield-shaped) are provided in each unit, to be selected according to physician preference.
Published 2024-12-30
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name QWU Prosthesis, Eyelid Spacer/Graft, Polymer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QWU Prosthesis, Eyelid Spacer/Graft, Polymer Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G16010440021 Package HIBCC 10 In Commercial Distribution G16010440020 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 531917352 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G16010362950 CorNeat EverPatch 1007691 1036295 2023-12-05 G16010440020 EverPatch+ 1044002 1044002 2024-12-30 G16010362951 CorNeat EverPatch 1007691 1036295 2023-12-05
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published G16010440020 EverPatch+ CORNEAT VISION LTD QWU 2024-12-30 G16010362950 CorNeat EverPatch CORNEAT VISION LTD QWU 2023-12-05 G16010362951 CorNeat EverPatch CORNEAT VISION LTD QWU 2023-12-05