Duns Number:080131031
Device Description: Synthetic bone void filler containing DBM for orthopedic applications
Catalog Number
NAN109-05
Brand Name
NanoFuse Bioactive Matrix - 5.0 cc
Version/Model Number
NAN109-05
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)
Yes
FDA Premarket Submission
K142104
Product Code
MBP
Product Code Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Public Device Record Key
02b8ece6-e882-4cc4-901c-0d3c3bb76055
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 12, 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. | 10 |