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Platinum Fiducial Marker MR-37505

by Izi Medical Products LLC

Listed FDA GUDID listing, no authorization on record

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB887MR375050 UDI-DI Date22 Oct 2025ListedStatusListed GUDID: 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  • Withdrawn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
Platinum Fiducial Marker
Generic Name
Radiological image marker, implantable
Model / Reference
MR-37505
Primary DI / UDI-DI
B887MR375050
FDA Product Code
IYE
GMDN Term
Radiological image marker, implantable
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

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Properties

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

Other properties (8)

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