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Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots

FDA UDI

Class II (US FDA UDI)

by Alpha Omega Engineering Corp.

Identity

Trade Name
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots FDA UDI
Generic Name
Depth electrode FDA UDI
Model / Reference
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots FDA UDI

Identifiers

Catalog Number
NOW-DFF000-00 FDA UDI
Primary DI / UDI-DI
27290114063191 FDA UDI
510(k) Number
K171581 FDA UDI
FDA Product Code
GZL FDA UDI
GMDN Term
Depth electrode 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

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: Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Depth electrode.

Cleared under the same submission

K171581 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alpha Omega Engineering Corp.

Sources (1)

  • FDA UDI dcb7db5d-027c-4b47-9b3d-2b7b093d6186 34 fields · synced Jun 8, 2026