Duns Number:830350380
Device Description: DBM A43204 0.25CC GRAFTON PUTTY SYRINGE
Catalog Number
-
Brand Name
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Version/Model Number
A43204
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 11, 2016
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
K051195
Product Code
MBP
Product Code Name
Filler, bone void, osteoinduction (w/o human growth factor)
Public Device Record Key
46567725-2fbf-451f-8c9d-4acb38dfffcd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 20, 2015
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 | 13352 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 26085 |
| 3 | A medical device with high risk that requires premarket approval | 190 |
| U | Unclassified | 75 |