microTargeting™ Procedure Kit - microTargeting Platform Procedure Consumables - FHC, INC.

Duns Number:108179458

Device Description: microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Dr microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor66-EL-LP: Patient Lead for Guideline 4000 LP+66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id

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More Product Details

Catalog Number

KT-PPK-S

Brand Name

microTargeting™ Procedure Kit

Version/Model Number

KT-PPK-S-00366

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

Yes

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

K011775,K011992,K071364

Product Code Details

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Device Record Status

Public Device Record Key

01f77907-39d7-4565-875d-0e9bf8138f33

Public Version Date

December 22, 2021

Public Version Number

7

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