Duns Number:333623937
Device Description: PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALAC PALACOS® R is a fast-curing, radiopaque, poly(methyl methacrylate)-based bone cement.PALACOS ® R contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS ® R has been coloured with chlorophyll (E141). The bone cement is prepared directly before use by mixing a polymer powder component with a liquid monomer component. A ductile dough forms which cures within a few minutes.
Catalog Number
5036963
Brand Name
PALACOS®
Version/Model Number
R
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K030902,K030902,K030902
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
f6390ec3-27df-4415-aba9-cacc818d8bd2
Public Version Date
June 19, 2020
Public Version Number
7
DI Record Publish Date
January 01, 2018
Package DI Number
04260102135529
Quantity per Package
400
Contains DI Package
04260102135505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |