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Isis

FDA UDI

Class II (US FDA UDI)

by inomed Medizintechnik GmbH

Identity

Trade Name
ISIS FDA UDI
Generic Name
Nerve-function monitor FDA UDI
Device Name
ISIS Headbox 8 Ch. Dif- 8 Ch. REF- AEP FDA UDI
Model / Reference
504285 FDA UDI
Description
ISIS Headbox 8 Ch. Dif- 8 Ch. REF- AEP FDA UDI

Identifiers

Primary DI / UDI-DI
04250307607563 FDA UDI
FDA Product Code
GWF FDA UDI
GMDN Term
Nerve-function monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1870 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Nerve-function monitor

Isis by inomed Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve-function monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
inomed Medizintechnik GmbH

Sources (1)

  • FDA UDI b228bb65-64f0-440c-8c53-9dcb27998b63 33 fields · synced Jun 8, 2026