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Tip Sample Box (Neonate) NEO-BOX

by Otodynamics

Tip Sample Box (Neonate) NEO-BOX is a Class II device made by Otodynamics, listed in FDA GUDID since 1 Apr 2023 (UDI-DI 05060396172595), 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 Number05060396172595 UDI-DI Date1 Apr 2023ListedStatusListed 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  • Withdrawn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
Tip Sample Box (Neonate)
Generic name
Evoked-potential audiometer
Model / reference
NEO-BOX
Primary DI / UDI-DI
05060396172595
FDA product code
EWO, GWJ
GMDN term
Evoked-potential audiometer
Device class
Class II
Regulation number
874.1050, 882.1900
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

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

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Properties

  • Single use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)