AccessGUDID - DEVICE: Lightbox Umbilical (00851354004127)

GUDID

Device Identifier (DI) Information

Brand Name: Lightbox Umbilical
Version or Model: U100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U100
Company Name: AVINGER, INC.

Primary DI Number: 00851354004127
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 003152968 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59224	Mechanical atherectomy system generator, mechanical output	A mains electricity (AC-powered) component of a mechanical atherectomy system designed to generate mechanical energy that is typically transmitted through a separate catheter/handpiece for the fragmentation of a chronic partial occlusion (CPO) or chronic total occlusion (CTO) of both coronary and peripheral arteries during an atherectomy procedure. The device may be operated via a remote control or foot-switch and may include an integrated suction/aspiration system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PDU	Catheter For Crossing Total Occlusions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e6c03753-3fc1-4d86-af3e-09840429266d
Public Version Date: March 29, 2019
Public Version Number: 1
DI Record Publish Date: March 21, 2019