Catalog Number

06212SC

Brand Name

Tropocells

Version/Model Number

06212SC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 05, 2020

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

-

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

BK110035

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Public Device Record Key

287559fe-f44d-42ad-93aa-9b9878f09913

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

October 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-