microTargeting™ Electrode and Insertion Tube Kit - microTargeting D.ZAP Electrode Kit, 5x, Sterile, - FHC, INC.

Duns Number:108179458

Device Description: microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive.Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode.1x IT(DB3) Insertion tube with Stylet.1x PT(DB5) Protective Tube.Individual Specifications:MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L)IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id

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More Product Details

Catalog Number

FC4001

Brand Name

microTargeting™ Electrode and Insertion Tube Kit

Version/Model Number

FC4001-00754

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,K033173,K011775,K033173

Product Code Details

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Device Record Status

Public Device Record Key

d068c9b6-7fb6-4bfd-807d-16046f3ba2eb

Public Version Date

January 06, 2020

Public Version Number

1

DI Record Publish Date

December 27, 2019

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