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NeuroSmart with AutoClavable Drive Headstage

FDA UDI

Class II (US FDA UDI)

by Alpha Omega Engineering Corp.

Identity

Trade Name
NeuroSmart with AutoClavable Drive Headstage FDA UDI
Generic Name
Depth electrode FDA UDI
Model / Reference
Rev. 5 FDA UDI
NeuroSmart with AutoClavable Drive Headstage FDA UDI

Identifiers

Catalog Number
NSW-006008-55 FDA UDI
Primary DI / UDI-DI
27290114060916 FDA UDI
27290114060442 FDA UDI
510(k) Number
K172042 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

Yes

FDA UDIFDA 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
Sterilization Method
Dry Heat Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Depth electrode

NeuroSmart with AutoClavable Drive Headstage by Alpha Omega Engineering Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Depth electrode.

Cleared under the same submission

K172042 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 (2)

  • FDA UDI c7d088f0-4503-4a9b-bf00-8cb5911b1e0b 34 fields · synced Jun 8, 2026
  • FDA UDI efabbf73-07fb-44e8-a12c-85e17bddde7f 34 fields · synced May 27, 2026