EverPatch+

Primary DI
G16010440020
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
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QWUProsthesis, Eyelid Spacer/Graft, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QWUProsthesis, Eyelid Spacer/Graft, PolymerOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G16010440021PackageHIBCC10In Commercial Distribution
G16010440020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbableAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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 DIBrandModelCatalogPublished
G16010362950CorNeat EverPatch100769110362952023-12-05
G16010440021EverPatch+104400210440022024-12-30
G16010362951CorNeat EverPatch100769110362952023-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G16010440021EverPatch+CORNEAT VISION LTDQWU2024-12-30
G16010362950CorNeat EverPatchCORNEAT VISION LTDQWU2023-12-05
G16010362951CorNeat EverPatchCORNEAT VISION LTDQWU2023-12-05