Duns Number:828813290
Device Description: Synthetic bone void filler for orthopedic applications
Catalog Number
NB3815
Brand Name
Porous Morsels Syringe 2-5mm 15.0cc
Version/Model Number
NB3815
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
K090731
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
51af643f-3a53-4d7b-995a-b5c6854b6123
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
March 07, 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. | 80 |