Catalog Number

00020013100

Brand Name

HemosIL D-Dimer HS 500 Controls (Liquid)

Version/Model Number

00020013100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K133582

Product Code

GGN

Product Code Name

PLASMA, COAGULATION CONTROL

Public Device Record Key

61b92614-4ca6-41eb-990e-277a68a22b8a

Public Version Date

July 13, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-