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 ID: 00851354004301
• NIH Device Record Key: ac2def24-cf8f-4d6b-96d5-f8e8c00df2a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lightbox Umbilical
• Version Model Number: U250
• Catalog Number: U250
• Company DUNS: 003152968
• Company Name: AVINGER, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-241-7030
• Email: tlawson@avinger.com
• Phone: 650-241-7030
• Email: tlawson@avinger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851354004301 [Primary]

FDA Product Code

• NQQ: System, Imaging, Optical Coherence Tomography (Oct)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

On-Brand Devices [Lightbox Umbilical ]

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