Duns Number:832629898
Device Description: VITRIUM E20 x 7
Catalog Number
-
Brand Name
Bio2 Technologies
Version/Model Number
1000043
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K142463,K152589
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
861f9f30-c8fe-440f-bd1b-7368d8e2bd05
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 01, 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. | 45 |