Catalog Number

M004210057A0

Brand Name

TempLink™

Version/Model Number

M004210057A0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

P000020

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

b18ae24b-0d8a-46ae-be1e-82b21bbd1c74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-