Home GUDID G16010362950
CorNeat EverPatch
Primary DI G16010362950
Brand CorNeat EverPatch
Company CORNEAT VISION LTD
Model 1007691
Catalog number 1036295
Device description Permanent Tissue-Integrating Surgical Matrix
Published 2023-12-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
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 G16010362951 Package HIBCC 10 In Commercial Distribution G16010362952 Package HIBCC 40 In Commercial Distribution G16010362950 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., polycarbonate (PC), 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
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 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G16010440020 EverPatch+ 1044002 1044002 2024-12-30 G16010440021 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 G16010440021 EverPatch+ CORNEAT VISION LTD QWU 2024-12-30 G16010362951 CorNeat EverPatch CORNEAT VISION LTD QWU 2023-12-05