Duns Number:042763706
Device Description: MinerOss®X CANCELLOUS PARTICLE SIZE 250-1000µ 0.5G/1.0CC
Catalog Number
BH0022
Brand Name
MinerOss® X
Version/Model Number
MINX-CAN0.5GR
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
NPM
Product Code Name
BONE GRAFTING MATERIAL, ANIMAL SOURCE
Public Device Record Key
9ad45d39-eb01-47d9-9309-1f351ba3e797
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 06, 2017
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 | 1288 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 943 |
| U | Unclassified | 6 |