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STar™ Drive Insertion Tube Set

FDA UDI

Class I (US FDA UDI)

by Fhc, Inc.

Identity

Trade Name
STar™ Drive Insertion Tube Set FDA UDI
Generic Name
Intracerebral cannula, nonimplantable, reusable FDA UDI
Device Name
STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet - 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id. 2x Insertion Tube Extractors FDA UDI
Model / Reference
70-IT-04-00218 FDA UDI
Description
STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet - 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id. 2x Insertion Tube Extractors FDA UDI

Identifiers

Catalog Number
70-IT-04 FDA UDI
Primary DI / UDI-DI
00873263002186 FDA UDI
FDA Product Code
HAO FDA UDI
HAW FDA UDI
GMDN Term
Intracerebral cannula, nonimplantable, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4535 FDA UDI
882.4560 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Intracerebral cannula, nonimplantable, reusable

STar™ Drive Insertion Tube Set by Fhc, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracerebral cannula, nonimplantable, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fhc, Inc.

Sources (1)

  • FDA UDI 40014ed6-df86-4dd3-9f4f-c426e4ec803b 36 fields · synced May 30, 2026