ABR / ASSR Lead Cable Set

FDA UDI

Class II (US FDA UDI)

by PATH medical GmbH

Identity

Trade Name: ABR / ASSR Lead Cable Set FDA UDI
Generic Name: Evoked-potential audiometer FDA UDI
Device Name: ABR / ASSR electrode lead cable set FDA UDI
Model / Reference: 100891-1 FDA UDI
Description: ABR / ASSR electrode lead cable set FDA UDI

Identifiers

Primary DI / UDI-DI: 04260223143328 FDA UDI
FDA Product Code: IKD FDA UDI
GMDN Term: Evoked-potential audiometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1175 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Evoked-potential audiometer

ABR / ASSR Lead Cable Set by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: PATH medical GmbH

Sources (1)

FDA UDI a4d8bfe4-90e9-4a3e-a9de-a98ce88614c7 33 fields · synced Jun 8, 2026