Duns Number:079316474
Device Description: Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery device designed Osseoflex® CD-H Hydraulic Cement Delivery system is a bone cement delivery device designed to allow the physician to keep a safer distance from the radiation source during the cement delivery phase in vertebroplasty, vertebral augmentation procedures and the skeletal system.
Catalog Number
-
Brand Name
Osseoflex CD-H
Version/Model Number
OF-0348
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KIH
Product Code Name
Dispenser, Cement
Public Device Record Key
eeb922c0-6d8a-4a17-bb84-2aa03c60777c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
March 31, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |