Catalog Number

CYCP-60-02

Brand Name

Cyclone Platelet Rich Plasma (PRP) Concentrating System

Version/Model Number

CYCP-60-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

BK160045

Product Code

ORG

Product Code Name

Platelet and plasma separator for bone graft handling

Public Device Record Key

744e3969-b911-47c5-a9c1-f70fa59ebad9

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-