Duns Number:109903521
Device Description: DYONICS POWER II SHAVER SYSTEM CONTROL UNIT. ALL UNITS DYONICS POWER II SHAVER SYSTEM CONTROL UNIT. ALL UNITS 100-240 VAC, 50/60 HZ SERVICE REPLACEMENT
Catalog Number
72200873S
Brand Name
NA
Version/Model Number
72200873S
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
HRX
Product Code Name
ARTHROSCOPE
Public Device Record Key
7ad53f2d-38c7-4d48-af4b-0b81c9aebf27
Public Version Date
July 04, 2022
Public Version Number
4
DI Record Publish Date
September 28, 2015
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 | 10651 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
| 3 | A medical device with high risk that requires premarket approval | 351 |