Catalog Number

IN4430/K

Brand Name

basixCOMPAK™

Version/Model Number

00884450638354

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

d024ee27-be86-41d2-aa10-f13e36318b23

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 25, 2022

Package DI Number

10884450638351

Quantity per Package

10

Contains DI Package

00884450638354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-