Catalog Number

00988800

Brand Name

VYGON

Version/Model Number

9888.00

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

1e405773-9f09-40a9-ace7-9843e93962f8

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Package DI Number

53660812021062

Quantity per Package

10

Contains DI Package

33660812021068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case