Catalog Number

115.11

Brand Name

VYGON

Version/Model Number

115.11

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

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Public Device Record Key

d4a9f88d-022a-4617-9381-8b6de446e43a

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

33660812000421

Quantity per Package

20

Contains DI Package

03660812000420

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-