← Back to catalogue

NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable)

FDA UDI

Class II (US FDA UDI)

by Alpha Omega Engineering Corp.

Identity

Trade Name
NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) FDA UDI
Generic Name
Depth electrode FDA UDI
Model / Reference
NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) FDA UDI

Identifiers

Catalog Number
700-026008-00 FDA UDI
Primary DI / UDI-DI
27290114063153 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

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
Sterilization Method
Dry Heat Sterilization FDA UDI

Category: Depth electrode

NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) 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

K172042 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Alpha Omega Engineering Corp.

Sources (1)

  • FDA UDI f846004a-ff49-4f25-8cd0-e15e24e90885 34 fields · synced Jun 6, 2026