Catalog Number

755210040

Brand Name

Skater™ Biliary Drainage Catheter Non-Locking

Version/Model Number

10Fr x 40cm

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

-

Product Code

FGE

Product Code Name

Catheter, Biliary, Diagnostic

Public Device Record Key

19f13c82-31e7-4b9b-b5e4-d42e0188b628

Public Version Date

November 19, 2020

Public Version Number

3

DI Record Publish Date

October 23, 2015

Package DI Number

20886333001358

Quantity per Package

5

Contains DI Package

00886333001354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box