Catalog Number

-

Brand Name

G3 40 Radiopaque Bone Cement

Version/Model Number

800004

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

K193061

Product Code

LOD

Product Code Name

Bone Cement

Public Device Record Key

7f24be8d-26c2-4b53-b382-d152dad8ab68

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-