Catalog Number

MBD-AM-BA-2

Brand Name

NA

Version/Model Number

MBD-AM-BA-2

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

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

2b544947-4732-4d1c-81d1-4c1fe7ee4d51

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 29, 2016

Package DI Number

26932503523022

Quantity per Package

1

Contains DI Package

16932503523025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case