microTargeting™ Electrode and Insertion Tube Kit - microTargeting Frame Kit D.ZAP/Lead Insertion, - FHC, INC.

Duns Number:108179458

Device Description: microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive. Contains: 34685L: Single D.ZAP Electrode. 66-DA-SD: Drape Sleeve. 66-EL-LP: Patient Lead for LP+. 66-IT-05P: Single Insertion Tube Set.

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More Product Details

Catalog Number

KT-FPK-S20

Brand Name

microTargeting™ Electrode and Insertion Tube Kit

Version/Model Number

KT-FPK-S20-00508

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,K033173

Product Code Details

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Device Record Status

Public Device Record Key

4b6f5ea5-0801-4ee9-8273-44125bc7de2f

Public Version Date

September 23, 2019

Public Version Number

4

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