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B81 Bone Vibrator Cable M014403

by Intelligent Hearing Systems Corp.

B81 Bone Vibrator Cable M014403 is a Class II device made by Intelligent Hearing Systems Corp., listed in FDA GUDID since 9 Jun 2026 (UDI-DI 00817020021010), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817020021010 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
B81 Bone Vibrator Cable
Generic name
Auditory cranial bone vibrator
Model / reference
M014403
Primary DI / UDI-DI
00817020021010
FDA product code
EWO
GMDN term
Auditory cranial bone vibrator
Device class
Class II
Regulation number
874.1050
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)