Catalog Number

007124

Brand Name

DURAGLIDE

Version/Model Number

007124

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

K993892,K993892

Product Code

FGE

Product Code Name

Stents, drains and dilators for the biliary ducts

Public Device Record Key

1b677286-7c76-4ead-ac20-014ce52f9d8c

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

October 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-