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Lightbox Umbilical U250

by Avinger, Inc.

Lightbox Umbilical U250 is a Class II device made by Avinger, Inc., listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004301), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00851354004301 UDI-DI Date21 Mar 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Lightbox Umbilical
Generic name
Mechanical atherectomy system generator, mechanical output
Model / Ref / Catalog
U250
Primary DI / UDI-DI
00851354004301
FDA product code
NQQ
GMDN term
Mechanical atherectomy system generator, mechanical output
Device class
Class II
Regulation number
892.1560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Mechanical atherectomy system generator, mechanical output

Similar devices

Other devices filed under FDA product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)).

Other devices from Avinger, Inc.

See all devices from Avinger, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)