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Relay Plus Thoracic Stent-Graft System 28-M338190342590U

by Bolton Medical Inc. 2 variants

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 Number08435761002314 UDI-DI Date13 Jun 2019ListedStatusListed 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  • Withdrawn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 Plus Thoracic Stent-Graft System
Generic Name
Descending thoracic aorta/aortic isthmus endovascular stent-graft
Model / Ref / Catalog
28-M338190342590U
Primary DI / UDI-DI
08435761002314
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
Outer Diameter — 34 Millimeter
Length — 190 Millimeter
Outer Diameter — 38 Millimeter
Catheter Gauge — 25 French

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