Duns Number:129278169
Device Description: DBM in a Lipid Carrier with Porous Calcium Granules
Catalog Number
DBMW02
Brand Name
InterGro DBM Plus
Version/Model Number
DBMW02
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)
Yes
FDA Premarket Submission
K082793
Product Code
GXP
Product Code Name
Methyl Methacrylate For Cranioplasty
Public Device Record Key
a614d2a5-50ae-4b6f-b9c7-26d8431000c6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 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 | 11962 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28376 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |