Catalog Number

-

Brand Name

RegenKit®-BCT-1

Version/Model Number

RK-BCT-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2021

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

BK110061

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Public Device Record Key

e773e297-22bb-41de-b712-584e687474c4

Public Version Date

November 16, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-