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Gore BXB103902A

by W. L. Gore & Associates, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00733132665006 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0077-2022 FDA Class II initiated 7 Sep 2021

    Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Gore
Generic Name
Peripheral artery endovascular stent-graft, drug-coated
Model / Ref / Catalog
BXB103902A
Primary DI / UDI-DI
00733132665006
PMA Number
FDA Product Code
PRL
GMDN Term
Peripheral artery endovascular stent-graft, drug-coated
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (P160021)

Show all (12)

Other devices from W. L. Gore & Associates, Inc.

See all devices from W. L. Gore & Associates, Inc. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Serial Number

Other properties (10)

  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No