NeuroNav Headstage cable

FDA UDI

Class II (US FDA UDI)

by Alpha Omega Engineering Corp.

Identity

Trade Name: NeuroNav Headstage cable FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Model / Reference: Headstage cable FDA UDI

Identifiers

Catalog Number: 190-000375-00 FDA UDI
Primary DI / UDI-DI: 07290114061339 FDA UDI
510(k) Number: K120098 FDA UDI
FDA Product Code: GZL FDA UDI
GMDN Term: Neurological stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.1330 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Neurological stereotactic surgery system

NeuroNav Headstage cable by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Alpha Omega Engineering Corp.

Sources (1)

FDA UDI 843bc3c1-f8ea-43e6-976c-38220bf36c59 34 fields · synced May 29, 2026