Catalog Number

402839

Brand Name

Safire™ TX

Version/Model Number

402839

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

P040042

Product Code

OAD

Product Code Name

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Public Device Record Key

5138558c-faa8-4350-be35-f6aa6d9fc3f3

Public Version Date

January 28, 2019

Public Version Number

3

DI Record Publish Date

September 29, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-