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Standard TruGuard HNRT-3501

by Qfix

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 Number10841439115227 UDI-DIDate12 Jun 2026ListedStatusListed 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  • Withdrawn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
Standard TruGuard
Generic Name
Patient positioning thermoplastic mould material
Model / Ref / Catalog
HNRT-3501
Primary DI / UDI-DI
10841439115227
510(k) Number
FDA Product Code
IYE
GMDN Term
Patient positioning thermoplastic mould material
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K153270)

Other devices from Qfix

See all devices from Qfix →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • 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