Duns Number:436664734
Device Description: PS MEDICAL TORQUE WRENCH is a torque wrench used for tightening inserts to the Mectron ult PS MEDICAL TORQUE WRENCH is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
Catalog Number
02900080-001
Brand Name
MECTRON
Version/Model Number
PS MEDICAL TORQUE WRENCH
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
-
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
b495a46c-893f-4d0a-a2ec-a648ed4d7641
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 30, 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 |