Endovascular Laser Vein System (ELVeS®) Kit 101235

GUDID 04049089200280

Ceram Optec SIA

Varicose vein lasing procedure kit
Primary Device ID04049089200280
NIH Device Record Key31275c58-b930-43de-be81-8cf3f4d58860
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndovascular Laser Vein System (ELVeS®) Kit
Version Model NumberELVeS® Radial® Kit 6Fx7cm
Catalog Number101235
Company DUNS506069240
Company NameCeram Optec SIA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049089100283 [Primary]
GS104049089200280 [Package]
Contains: 04049089100283
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-31

On-Brand Devices [Endovascular Laser Vein System (ELVeS®) Kit]

04049089200297ELVeS® Radial® Slim Kit 4Fx11cm
04049089200280ELVeS® Radial® Kit 6Fx7cm
04049089200273ELVeS® Radial® Slim Kit 4Fx7cm
04049089200266ELVeS® Radial® Kit 6Fx11cm

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