REFOBACIN® BONE CEMENT R - BIOMET

Duns Number:260930126

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

110034358

Brand Name

REFOBACIN® BONE CEMENT R

Version/Model Number

110034358

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LOD

Product Code Name

BONE CEMENT

Device Record Status

Public Device Record Key

75f0c12f-7c11-4098-b4f6-879e1249bb2f

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

March 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 6