Duns Number:828813290
Device Description: Synthetic bone void filler for orthopedic applications
Catalog Number
NB0602
Brand Name
Putty 2.5cc
Version/Model Number
NB0602
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
K082672
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
d34a21a8-41ec-4441-a8d7-4c05a8bbb411
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 |