Catalog Number

34385Z

Brand Name

microTargeting™ Electrode

Version/Model Number

34385Z-00794

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

ac999b30-af3c-4c85-a5c6-06633d0e2ae3

Public Version Date

September 23, 2019

Public Version Number

2

DI Record Publish Date

August 24, 2019

Package DI Number

10873263007942

Quantity per Package

5

Contains DI Package

00873263007945

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK/5