Catalog Number

-

Brand Name

Single Use Biliary Drainage Stent V

Version/Model Number

PBD-1032-1211

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

K103478,K103478

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

5375f60d-dcc9-4201-bc71-050d06c9d61c

Public Version Date

December 08, 2021

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

14953170347204

Quantity per Package

1

Contains DI Package

04953170347207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-