Catalog Number

007124

Brand Name

DURAGLIDE

Version/Model Number

007124

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2020

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)

Yes

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

K993892

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Public Device Record Key

62be3c31-b33a-4da9-aa06-195ebb58aed3

Public Version Date

November 19, 2020

Public Version Number

5

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-