Catalog Number

TBK05110SSG

Brand Name

TB

Version/Model Number

TBK05110SSG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2018

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

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

K861403

Product Code

LDF

Product Code Name

Electrode, Pacemaker, Temporary

Public Device Record Key

ce9d9919-d5e9-4bfe-95f6-f547b6429955

Public Version Date

July 24, 2020

Public Version Number

5

DI Record Publish Date

October 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-