Duns Number:493710719
Device Description: Synthetic Resorbable Bone Graft Granules
Catalog Number
9902G02
Brand Name
MBCP
Version/Model Number
9902G02
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)
Yes
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
K051885
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
12d79c91-82c7-4720-a37e-34f2461b4fa1
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
May 11, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 210 |