Catalog Number

CER-PRP-60-BD

Brand Name

Cervos Platelet Separator Triple Pack with Blood Draw

Version/Model Number

CER-PRP-60-BD

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,BK200543

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Public Device Record Key

07b012c3-fe89-47f0-bc65-616e881dc7f2

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

10858690006584

Quantity per Package

1

Contains DI Package

00858690006587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack