Lightbox Umbilical U250

GUDID 00851354004301

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
Primary Device ID00851354004301
NIH Device Record Keyac2def24-cf8f-4d6b-96d5-f8e8c00df2a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightbox Umbilical
Version Model NumberU250
Catalog NumberU250
Company DUNS003152968
Company NameAVINGER, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone650-241-7030
Emailtlawson@avinger.com
Phone650-241-7030
Emailtlawson@avinger.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851354004301 [Primary]

FDA Product Code

NQQSystem, Imaging, Optical Coherence Tomography (Oct)

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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