Catalog Number

M0045086TK20

Brand Name

Blazer® II

Version/Model Number

M0045086TK20

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

P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047

Product Code

LPB

Product Code Name

Cardiac ablation percutaneous catheter

Public Device Record Key

b2863880-cee2-40aa-a23e-2b013d388d45

Public Version Date

September 16, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-