Catalog Number

CF-s25x25x3

Brand Name

CellFUSE

Version/Model Number

CF-s25x25x3

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"

-

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

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

1379ca58-bf8b-43d2-9a18-0a369ed3cf2a

Public Version Date

October 30, 2020

Public Version Number

1

DI Record Publish Date

October 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-