microTargeting™ Electrode and Insertion Tube - microTargeting single electrode insertion tubes - FHC, INC.

Duns Number:108179458

Device Description: microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use wi microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications:MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

FC4000

Brand Name

microTargeting™ Electrode and Insertion Tube

Version/Model Number

FC4000-00753

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

7dd5bc1d-b058-42b8-a07e-b5b518d6bad5

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