Catalog Number

1159.15

Brand Name

VYGON

Version/Model Number

1159.15

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

eb6eb893-5896-4898-9300-56c9582fcc4d

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

53660812010967

Quantity per Package

6

Contains DI Package

33660812010963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-