Duns Number:793384496
Device Description: resorbable porous calcium phosphate bone void filler 25 x 50 x 8mm; 10 cc
Catalog Number
90-400-25508
Brand Name
nanOss® 3D Plus™
Version/Model Number
90-400-25508
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
K132050
Product Code
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
d4683404-4e90-40c3-b0f1-a7d4b0cdffff
Public Version Date
October 14, 2021
Public Version Number
3
DI Record Publish Date
September 19, 2018
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 | 3116 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |