Duns Number:832270370
Device Description: Kit Contains: (1) 003-AGL, 3cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, Marro Kit Contains: (1) 003-AGL, 3cc Agilon Moldable Bone Grafting Product, (1) MC-RAN-8C, MarrowCellution Bone Marrow Biopsy Kit
Catalog Number
BGS-8C-003-AGL
Brand Name
DirectCell Advanced Bone Grafting System
Version/Model Number
BGS-8C-003-AGL
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
-
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
03ce89fe-d858-4dc7-ae4b-e5883c9e1b75
Public Version Date
February 04, 2021
Public Version Number
2
DI Record Publish Date
August 18, 2020
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. | 75 |