Zilver 635 - Zilver 635 Biliary Stent, Expandable Metal - COOK IRELAND LTD

Duns Number:988559035

Device Description: Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System

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More Product Details

Catalog Number

ZILBS-635-8-8

Brand Name

Zilver 635

Version/Model Number

G50623

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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 Details

Product Code

FGE

Product Code Name

CATHETER, BILIARY, DIAGNOSTIC

Device Record Status

Public Device Record Key

c161e231-9b0f-472b-a560-d1fe39fd4448

Public Version Date

April 08, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COOK IRELAND LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 888
3 A medical device with high risk that requires premarket approval 165