Catalog Number

D134802

Brand Name

THERMOCOOL SMARTTOUCH SF

Version/Model Number

D134802

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

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

P030031

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

1f3cf053-9fd7-46cd-ad83-f7dc1c126786

Public Version Date

June 07, 2022

Public Version Number

6

DI Record Publish Date

November 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-