Catalog Number

IN4902/A

Brand Name

basixCOMPAK™

Version/Model Number

00884450638415

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

75ab910d-b6ec-4bf9-bba6-07f9275aa8cb

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

10884450638412

Quantity per Package

10

Contains DI Package

00884450638415

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-