Duns Number:436664734
Device Description: UNIVR is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery UNIVR is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery ultrasonic handpieces.
Catalog Number
03600008
Brand Name
MECTRON
Version/Model Number
UNIVR
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
K153743
Product Code
DZI
Product Code Name
Drill, Bone, Powered
Public Device Record Key
d4ae64e0-1666-484a-9a5a-29aff0c5adf8
Public Version Date
July 24, 2018
Public Version Number
4
DI Record Publish Date
September 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 45 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 199 |