Duns Number:832270370
Device Description: Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Kit Contains: (1) 020-AGS, Large Agilon Strip Bone Grafting Product, (1) MC-RAN-8C, Marrow Cellution Bone Marrow Biopsy Kit
Catalog Number
BGS-8C-020-AGS
Brand Name
DirectCell Advanced Bone Grafting System
Version/Model Number
BGS-8C-020-AGS
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
K190177,K193487
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
faa24720-3b30-45b5-b87e-7389e11c55ed
Public Version Date
March 04, 2021
Public Version Number
1
DI Record Publish Date
February 24, 2021
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 |