Duns Number:344261631
Device Description: Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pa
Catalog Number
08.702.017S
Brand Name
Vertecem II Cement Kit
Version/Model Number
08.702.017S
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
-
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
c39685df-bd2f-4d59-a0b8-a22319c3f060
Public Version Date
February 14, 2020
Public Version Number
4
DI Record Publish Date
October 21, 2015
Package DI Number
14260056880756
Quantity per Package
21
Contains DI Package
04260056880759
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping unit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |