Duns Number:315304071
Device Description: MOTOR CONTROL UNIT 2304 for Orthopedics, Spine surgery and Bronchoscopy, for connection o MOTOR CONTROL UNIT 2304 for Orthopedics, Spine surgery and Bronchoscopy, for connection of handpieces M4, M5/0, M5/3, S1 and M1, connection for two handpieces and a footswitch, 5.7inch monochrome Display, compatible with core, U: 120VAC, 50/60Hz, Dim. (wxhxd): 330x155x365mm
Catalog Number
2304.007
Brand Name
POWER DRIVE ART1
Version/Model Number
2304007
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
0ff2579f-4ab4-4527-a246-7d5222e7caac
Public Version Date
October 18, 2022
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 |