Catalog Number

IN4T802

Brand Name

basixTau™

Version/Model Number

00884450413449

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PTM

Product Code Name

Syringe, Balloon Inflation, Exempt

Public Device Record Key

4865728b-cc6e-4ea6-831f-5cde62242e46

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Package DI Number

20884450413443

Quantity per Package

2

Contains DI Package

10884450413446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-