Catalog Number

-

Brand Name

STA® - Stachrom® Plasminogen

Version/Model Number

00658

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

-

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

K832591

Product Code

DDX

Product Code Name

PLASMINOGEN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

41324679-3415-45a3-b70e-b38eb65ee925

Public Version Date

May 03, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-