Catalog Number

IN4917

Brand Name

basixCOMPAK™

Version/Model Number

00884450544662

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

MAV

Product Code Name

Syringe, balloon inflation

Public Device Record Key

6abd6737-baa1-4777-9dce-cff4c0d62f0f

Public Version Date

May 05, 2022

Public Version Number

1

DI Record Publish Date

April 27, 2022

Package DI Number

20884450544666

Quantity per Package

4

Contains DI Package

10884450544669

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-