Home GUDID 00850853006342 keraSys
Primary DI 00850853006342
Brand keraSys
Company Innovative Ophthalmic Products, Inc
Model TK-41015
Catalog number TK-41015
Device description Bio-engineered patch graft
Published 2016-01-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NXM Prosthesis, Eyelid Spacer/Graft, Biologic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NXM Prosthesis, Eyelid Spacer/Graft, Biologic Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850853006342 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 00850853006342 00850853006342 850853006342 0850853006342
GMDN Terms# Term, Definition table Term Definition Eyelid graft A device derived from animal tissues (porcine) that is prepared into sheets of various sizes and thicknesses appropriate for the grafting, reconstruction, and repair of the soft tissue of the eyelid. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 1.5 Centimeter Width 1 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Ambient Temperature
Regulatory Flags# DUNS number 793362583 Device count 1 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 00850853006328 tarSys TS-81040 TS-81040 2016-01-06 00850853006335 tarSys TS-121040 TS-121040 2016-01-06
Other Devices Sharing Product Codes# 
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