Catalog Number

SSP-395

Brand Name

VYGON

Version/Model Number

SSP-395

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K882503,K882503

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

c5f48418-4d69-48c0-bd4b-ce78aceee0ef

Public Version Date

March 20, 2020

Public Version Number

1

DI Record Publish Date

March 12, 2020

Package DI Number

30849884004428

Quantity per Package

50

Contains DI Package

00849884004427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-