Catalog Number

IN4852/H

Brand Name

basixCOMPAK™

Version/Model Number

00884450535257

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

13e968ea-abf8-4e89-829d-e7ada86e96f5

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 10, 2021

Package DI Number

20884450535251

Quantity per Package

4

Contains DI Package

10884450535254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-