Catalog Number

GS60-SP

Brand Name

PurePRP Supraphysiologic 60mL GenesisCS Component Concentrating System

Version/Model Number

GS60-SP

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

-

Product Code

ORG

Product Code Name

Platelet and plasma separator for bone graft handling

Public Device Record Key

f2f8c80f-81f1-4cb5-833b-aee94b85ed6e

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

January 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-