Duns Number:333623937
Device Description: PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. I PALACOS® LV+G is a slow-curing, radiopaque, poly(methyl methacrylate)-based bone cement. It contains the aminoglycoside antibiotic gentamicin.PALACOS® LV+G contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field PALACOS® LV+G 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
00-1119-140-01
Brand Name
PALACOS
Version/Model Number
LV+G
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050854
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
4cda6e5b-c429-4744-b820-42cd96484e16
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |