Catalog Number

CER-PRP-40-1

Brand Name

Cervos Platelet Separator Single Pack

Version/Model Number

CER-PRP-40-1

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"

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

BK200543,BK200543

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Public Device Record Key

4eec4f67-7353-4dcf-bdc5-2b9235a827e6

Public Version Date

November 18, 2021

Public Version Number

1

DI Record Publish Date

November 10, 2021

Package DI Number

10850023741544

Quantity per Package

20

Contains DI Package

00850023741547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case