Catalog Number

FS-BDC-10

Brand Name

Fusion

Version/Model Number

G49573

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171548

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Public Device Record Key

5dd6dfd0-031b-4275-a35f-d031b21b6c31

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-