Catalog Number

80246.10L

Brand Name

VYGON

Version/Model Number

80246.10L

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

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

b28bf36d-6820-43b2-8274-9d606d82eff8

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

53660812023585

Quantity per Package

24

Contains DI Package

33660812023581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-