Lightbox Umbilical U100

GUDID 00851354004127

Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product.

AVINGER, INC.

Mechanical atherectomy system generator, mechanical output Mechanical atherectomy system generator, mechanical output
Primary Device ID00851354004127
NIH Device Record Keye6c03753-3fc1-4d86-af3e-09840429266d
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightbox Umbilical
Version Model NumberU100
Catalog NumberU100
Company DUNS003152968
Company NameAVINGER, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004127 [Primary]

FDA Product Code

PDUCatheter For Crossing Total Occlusions

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-29
Device Publish Date2019-03-21

On-Brand Devices [Lightbox Umbilical ]

00851354004301Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a c
00851354004127Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a c

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