Catalog Number

70129-208/C

Brand Name

ALIMAXX-B®

Version/Model Number

00884450031087

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

1c5b1bca-f4c0-403c-b6b1-2e2e2e604342

Public Version Date

April 08, 2022

Public Version Number

5

DI Record Publish Date

September 18, 2016

Package DI Number

10884450031084

Quantity per Package

1

Contains DI Package

00884450031087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-