Duns Number:989925396
Device Description: Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical A Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. This System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
Catalog Number
C4609S
Brand Name
CUSA® Excel
Version/Model Number
C4609S
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
34c2da14-9036-4e77-816a-e9b1b033420d
Public Version Date
October 04, 2022
Public Version Number
5
DI Record Publish Date
January 27, 2017
Package DI Number
30381780026000
Quantity per Package
4
Contains DI Package
10381780026006
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 |