Catalog Number

A0210-08

Brand Name

CERAMENT™BONE VOID FILLER

Version/Model Number

A0210-08

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K073316

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

a98f4ab6-db42-4a11-97fd-226e61cf8674

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 17, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-