STar™ Drive Insertion Tube Set - STar(TM) Drive Array Electrode Insertion Tube Set - FHC, INC.

Duns Number:108179458

Device Description: STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform 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 id1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id.2x Insertion Tube Extractors

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More Product Details

Catalog Number

70-IT-04

Brand Name

STar™ Drive Insertion Tube Set

Version/Model Number

70-IT-04-00218

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HAO

Product Code Name

INSTRUMENT, SURGICAL, NON-POWERED

Device Record Status

Public Device Record Key

40014ed6-df86-4dd3-9f4f-c426e4ec803b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FHC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 476