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GN Otometrics A/S

FDA UDI

Class I (US FDA UDI)

by Natus Medical Denmark ApS

Identity

Trade Name
GN Otometrics A/S FDA UDI
Generic Name
Hearing aid/implant system programming interface unit FDA UDI
Device Name
1072 HI-PRO 2 FDA UDI
Model / Reference
Hearing Instrument Programmer FDA UDI
Description
1072 HI-PRO 2 FDA UDI

Identifiers

Catalog Number
8-04-14800 FDA UDI
Primary DI / UDI-DI
05713315000331 FDA UDI
FDA Product Code
ESD FDA UDI
GMDN Term
Hearing aid/implant system programming interface unit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hearing aid/implant system programming interface unit

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

Similar devices

Also classified as Hearing aid/implant system programming interface unit.

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 fad17763-ae44-453f-a25d-34d5b61eaae0 34 fields · synced May 30, 2026