Duns Number:071595540
Device Description: POWERPRO PNEUMATIC MODULAR HANDPIECE
Catalog Number
PRO6150
Brand Name
POWERPRO
Version/Model Number
PRO6150
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
-
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
DZI
Product Code Name
DRILL, BONE, POWERED
Public Device Record Key
ed6c9977-1f80-4520-b76b-a15a8b43ea00
Public Version Date
October 28, 2022
Public Version Number
3
DI Record Publish Date
September 24, 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 | 1412 |
2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
3 | A medical device with high risk that requires premarket approval | 95 |