Duns Number:333623937
Device Description: Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed f Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization
Catalog Number
66031896
Brand Name
OSTEOPAL®
Version/Model Number
V
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
K050085,K050085,K050085
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
ce596653-402c-44ef-a9ff-7bf008216078
Public Version Date
August 18, 2020
Public Version Number
1
DI Record Publish Date
August 10, 2020
Package DI Number
04260102130326
Quantity per Package
20
Contains DI Package
04260102130494
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |