Duns Number:989925396
Device Description: The CUSA Electrosurgical Module provides Desiccate Coagulation waveform electrosurgical ca The CUSA Electrosurgical Module provides Desiccate Coagulation waveform electrosurgical capability to CUSA® Excel handpieces. The CEM nosecone is intended for use with the CUSA® Excel/ CUSA® Excel+ UltrasonicSurgical Aspirator System, CUSA handpiece and the Covidien Force FX® Electrosurgical Generator. The CUSA handpiece with the CEM nosecone works in conjunction with the Force FX Generator in surgical procedureswhere combined ultrasonic dissection/electrosurgical coagulation is desired (simultaneously or independently).
Catalog Number
C6623
Brand Name
CUSA® Excel
Version/Model Number
C6623
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
Yes
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
LBK
Product Code Name
Device, neurosurgical fragmentation and aspiration
Public Device Record Key
5ec36b81-d9c5-4d05-83c2-b834733336f9
Public Version Date
October 04, 2022
Public Version Number
7
DI Record Publish Date
December 29, 2016
Package DI Number
30381780026123
Quantity per Package
6
Contains DI Package
10381780026129
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |