Catalog Number

110034355

Brand Name

Refobacin® Bone Cement R

Version/Model Number

110034355

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K171540

Product Code

LOD

Product Code Name

BONE CEMENT

Public Device Record Key

5bae58a2-e615-415a-a635-79df6d5a5330

Public Version Date

July 14, 2021

Public Version Number

4

DI Record Publish Date

March 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-