Catalog Number

010014-S1

Brand Name

Cook

Version/Model Number

G14463

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2017

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

EZN

Product Code Name

DILATOR, CATHETER, URETERAL

Public Device Record Key

81fadfec-2ffe-407e-ace3-2ef2917a84e4

Public Version Date

June 11, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-