Duns Number:830350380
Device Description: DBM P42308 GRAFTON MATRIX PLUGS 8MMX10MM
Catalog Number
-
Brand Name
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Version/Model Number
P42308
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
K051188
Product Code
NUN
Product Code Name
BONE GRAFTING MATERIAL, HUMAN SOURCE
Public Device Record Key
e6c37f46-7184-4adf-97fb-faf7cfc97895
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 |