Catalog Number

IN4914

Brand Name

basixCOMPAK™

Version/Model Number

00884450544631

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

2c8c23a8-63a0-4e37-9734-68836c6538f7

Public Version Date

April 27, 2021

Public Version Number

1

DI Record Publish Date

April 19, 2021

Package DI Number

20884450544635

Quantity per Package

4

Contains DI Package

10884450544638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-