Duns Number:989925396
Device Description: The extended life laparoscopic tip is intended for use withthe CUSA® Excel/ CUSA® Excel+ U The extended life laparoscopic tip is intended for use withthe CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical AspiratorSystem, CUSA® Handpiece and accessories. The CUSA ExcelSystem is indicated for use in these surgical procedures wherefragmentation, emulsification and aspiration of soft and hardtissue 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
-
Brand Name
CUSA® Excel
Version/Model Number
C4604ELTUS
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"
Yes
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
LBK
Product Code Name
Device, neurosurgical fragmentation and aspiration
Public Device Record Key
beceb743-8732-43cf-98e9-46a64b98b23b
Public Version Date
June 28, 2021
Public Version Number
5
DI Record Publish Date
December 29, 2016
Package DI Number
30381780248242
Quantity per Package
6
Contains DI Package
10381780248248
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 |