Duns Number:830350380
Device Description: DBM T44150INT 10CC GRAFTON ORTHOBLEND SM
Catalog Number
-
Brand Name
GRAFTON® DBM
Version/Model Number
T44150INT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
a78696fd-8e21-420a-b727-19dd5f340b64
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 07, 2019
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 |