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Horseshoe Headrest 116098-000

by IMRIS Imaging, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857534006882 UDI-DIDate21 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Horseshoe Headrest
Generic Name
Freestanding headrest, reusable
Model / Reference
116098-000
Primary DI / UDI-DI
00857534006882
FDA Product Code
HBM
GMDN Term
Freestanding headrest, reusable
Device Class
Class I
Regulation Number
882.4440
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from IMRIS Imaging, Inc.

See all devices from IMRIS Imaging, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

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