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Racer® Biliary XD512YL

by Medtronic, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

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 Number00613994551535 UDI-DI Date8 Jun 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1802-2010 FDA Unclassified (pre-2012) initiated 30 Jul 2009

    Mislabeling-- The incorrect Instructions for use may have been included with this product.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Racer® Biliary
Generic Name
Bare-metal biliary stent
Model / Reference
XD512YL
Primary DI / UDI-DI
00613994551535
510(k) Number
FDA Product Code
FGE
GMDN Term
Bare-metal biliary stent
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Length — 12.0 Millimeter

Other devices from Medtronic, Inc.

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

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