Catalog Number

-

Brand Name

XCELL

Version/Model Number

XC-RV-60 RegenVET

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ORG

Product Code Name

Platelet And Plasma Separator For Bone Graft Handling

Public Device Record Key

c9301619-4c0d-432c-814c-44d472c48f57

Public Version Date

April 19, 2021

Public Version Number

1

DI Record Publish Date

April 09, 2021

Package DI Number

B708XCRV601

Quantity per Package

10

Contains DI Package

B708XCRV600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case