Catalog Number

-

Brand Name

TrailBlazer™

Version/Model Number

SC-014-135

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

K092299,K092299

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

45c0b371-8f68-40b5-89b3-ff0fe81b5570

Public Version Date

September 22, 2022

Public Version Number

4

DI Record Publish Date

February 28, 2019

Package DI Number

20763000104744

Quantity per Package

5

Contains DI Package

00763000104740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK