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Relay Thoracic Stent-Graft with Plus Delivery System 28M334200302490U

by Bolton Medical Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08426950563624 UDI-DI Date22 Sep 2014ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Relay Thoracic Stent-Graft with Plus Delivery System
Generic Name
Descending thoracic aorta/aortic isthmus endovascular stent-graft
Model / Ref / Catalog
28M334200302490U
Primary DI / UDI-DI
08426950563624
PMA Number
FDA Product Code
MIH
GMDN Term
Descending thoracic aorta/aortic isthmus endovascular stent-graft
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 24 French
Outer Diameter — 34 Millimeter
Length — 200 Millimeter
Outer Diameter — 30 Millimeter

Related devices

Cleared under the same submission (P110038)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

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