Duns Number:315304071
Device Description: MOTOR CONTROL UNIT 2303 for Urology and Orthopedics, for connection of the motor handpiec MOTOR CONTROL UNIT 2303 for Urology and Orthopedics, for connection of the motor handpiece PIRANHA M4, connection possible to a motor handpiece and a footswitch, 5" LCD monochrome Display, communication interface for Piranha suction pump, U: 100-127/220-240 VAC, 50/60 Hz, Dim. (wxhxd): 330x100x360mm
Catalog Number
2303.011
Brand Name
POWER CONTROL
Version/Model Number
2303011
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEY
Product Code Name
MOTOR, SURGICAL INSTRUMENT, AC-POWERED
Public Device Record Key
ac19e662-8447-4e93-903f-7772b0977e1a
Public Version Date
April 21, 2021
Public Version Number
5
DI Record Publish Date
July 21, 2017
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |