Duns Number:830350380
Device Description: MINIGRANULES 8600100INT MASTERGRAFT .5CC
Catalog Number
-
Brand Name
MASTERGRAFT® Mini Granules
Version/Model Number
8600100INT
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
K082917,K082918
Product Code
LYC
Product Code Name
Bone grafting material, synthetic
Public Device Record Key
23148bcd-cfcb-4169-9ca0-e7a7ea7f1e31
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
November 18, 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 | 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 |