Catalog Number

G80005

Brand Name

Bone Filler Kit

Version/Model Number

G80005

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

K022074,K103433

Product Code

NDN

Product Code Name

Cement, Bone, Vertebroplasty

Public Device Record Key

31e8616c-85ca-42f1-9fa5-7b5e8b3b4613

Public Version Date

August 11, 2022

Public Version Number

4

DI Record Publish Date

November 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-