Home GUDID 00681490036115 Pulec
Primary DI 00681490036115
Brand Pulec
Company MEDTRONIC XOMED, INC.
Model 117200
Device description SHUNT 117200 PULEC ENDOLYMPHATIC C-FLEX
Published 2015-06-25
Public version status Update
Distribution status Not 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 ESZ TUBE, SHUNT, ENDOLYMPHATIC
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ESZ Tube, Shunt, Endolymphatic Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00681490036115 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 00681490036115 00681490036115 681490036115 0681490036115
GMDN Terms# Term, Definition table Term Definition Endolymphatic shunt A sterile tube or sheet surgically implanted in the membranous labyrinth of the inner ear to drain excess endolymphatic fluid typically as treatment for Meniere's disease, an inner ear disorder. The device permits unrestricted flow of the fluid from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. It is typically made of silicone. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 18.5 Millimeter
Regulatory Flags# DUNS number 835465063 Device count 1 Lot or batch true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00815347023588 Inner Ear Valved Shunt HOOD, E BENSON LABORATORIES INC ESZ 2016-07-07 00815347023601 Huang Inner Ear Shunt HOOD, E BENSON LABORATORIES INC ESZ 2016-07-07 00681490035798 Austin MEDTRONIC XOMED, INC. ESZ 2015-06-25 00681490035897 Austin MEDTRONIC XOMED, INC. ESZ 2015-06-25
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