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LUTONIX® Drug Coated Balloon BSLX3513061205F

by Lutonix, Inc.

Listed FDA GUDID listing, not in commercial distribution

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741123894 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
LUTONIX® Drug Coated Balloon
Generic Name
Peripheral angioplasty balloon catheter, drug-coated
Model / Ref / Catalog
BSLX3513061205F
Primary DI / UDI-DI
00801741123894
FDA Product Code
ONU
GMDN Term
Peripheral angioplasty balloon catheter, drug-coated
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No