Catalog Number

-

Brand Name

Silicone Biliary Stent

Version/Model Number

GR83064-056SP

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

K844384

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Public Device Record Key

37c0f5b9-9f29-4431-9da7-c8f525cac0a8

Public Version Date

November 19, 2020

Public Version Number

5

DI Record Publish Date

January 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-