Catalog Number

FC1001

Brand Name

microTargeting™ Electrode Sterilization Tray

Version/Model Number

FC1001-00653

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 28, 2021

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

4217ad22-31f7-4a61-9484-f09b6863dac8

Public Version Date

July 29, 2021

Public Version Number

3

DI Record Publish Date

September 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-