Duns Number:149183167
Device Description: Bone Graft Substitute, 1-4mm Morsels Cancellous Chips, Beta-Tricalcium Phosphate
Catalog Number
2102-0131
Brand Name
NA
Version/Model Number
2102-0131
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
MQV
Product Code Name
FILLER, BONE VOID, CALCIUM COMPOUND
Public Device Record Key
4e13a9c4-9c60-403f-b6a1-accbdc69d649
Public Version Date
November 03, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
30808232000215
Quantity per Package
10
Contains DI Package
00808232000214
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2688 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5304 |
| 3 | A medical device with high risk that requires premarket approval | 86 |