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BoneFoam 104.ARS-BX10

by Bone Foam, Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810075281552 UDI-DI Date12 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  • Withdrawn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
BoneFoam
Generic Name
Limb/torso/head restraint, single-use
Model / Ref / Catalog
104.ARS-BX10
Primary DI / UDI-DI
00810075281552
FDA Product Code
FMQ
GMDN Term
Limb/torso/head restraint, single-use
Device Class
Class I
Regulation Number
880.6760
GUDID distribution status
In Commercial Distribution

Other devices from Bone Foam, Inc.

See all devices from Bone Foam, Inc. →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

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