Catalog Number

35325Z

Brand Name

microTargeting™ Electrode

Version/Model Number

35325Z-00795

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K033173,K033173

Product Code

GZL

Product Code Name

ELECTRODE, DEPTH

Public Device Record Key

a905c69a-06b9-4b41-891c-cca7ebe7263c

Public Version Date

September 23, 2019

Public Version Number

2

DI Record Publish Date

August 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-