Duns Number:071595540
Device Description: Micropower Oral Max High Speed Drill, Detachable Lever
Catalog Number
00602002500
Brand Name
MICROPOWER
Version/Model Number
6020-025
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
K072706,K072706,K072706
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
298e6faa-93be-491f-8da1-fdecb0ca7e3c
Public Version Date
July 13, 2022
Public Version Number
2
DI Record Publish Date
September 03, 2020
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 |