Catalog Number

230-100

Brand Name

Transparent Disp. Tube Tolders (for HemataSTAT, Cream 50/pkg)

Version/Model Number

230-100

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

GKG

Product Code Name

Centrifuge, Hematocrit

Public Device Record Key

82c0b5a1-c7c0-416f-9bf1-5409cbf7e4b4

Public Version Date

April 18, 2018

Public Version Number

3

DI Record Publish Date

August 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-