Duns Number:687796909
Device Description: The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bo The OCS-B OsteoConductive Substitute-Bovine bone grafting material is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The OCS-B contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of OCS-B is effective for the regeneration of new bone around the grafted bone. The OCS-B has good osteoconductivity to enhance new bone formation. The OCS-Bs are supplied as cancellous (spongiosa) or cortical granules in single-use containers.
Catalog Number
-
Brand Name
OCS-B
Version/Model Number
S1-1020-200
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
K113246
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
709acec7-cbb8-430e-a58d-037202ee9920
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 102 |