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DP Tip Sample Box DP-BOX

by Otodynamics

DP Tip Sample Box DP-BOX is a Class II device made by Otodynamics, listed in FDA GUDID since 11 Aug 2016 (UDI-DI 05060396170409), 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 Number05060396170409 UDI-DI Date11 Aug 2016ListedStatusListed 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  • Withdrawn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
DP Tip Sample Box
Generic name
Otoacoustic emission system, line-powered
Model / reference
DP-BOX
Primary DI / UDI-DI
05060396170409
FDA product code
GWJ, EWO
GMDN term
Otoacoustic emission system, line-powered
Device class
Class II
Regulation number
882.1900, 874.1050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Evoked-potential audiometerOtoacoustic emission system, battery-poweredOtoacoustic emission system, line-powered

Other devices from Otodynamics

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Properties

  • Single use
Other properties (14, all answered No)