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GN Otometrics A/S

FDA UDI

Class II (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name
GN Otometrics A/S FDA UDI
Generic Name
Auditory stimulator FDA UDI
Model / Reference
"Eartip 4.5 mm red brown (50 pcs) FDA UDI

Identifiers

Catalog Number
8-68-31201 FDA UDI
Primary DI / UDI-DI
05713315003356 FDA UDI
FDA Product Code
GWJ FDA UDI
GMDN Term
Auditory stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Auditory stimulator

GN Otometrics A/S by Natus Medical Denmark ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Auditory stimulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Natus Medical Denmark ApS

Sources (1)

  • FDA UDI 1f367c12-19a1-46a1-aca7-2ada5a748b91 33 fields · synced May 30, 2026