Duns Number:989925396
Device Description: The manifold tubing connects the handpiece to the IV fluid, and connects the handpiece to The manifold tubing connects the handpiece to the IV fluid, and connects the handpiece to the suction canister on the CUSA® Excel. The manifold tubing supplies IV fluid to the handpiece for use at the surgical site, and it removes fragmented tissue and IV fluid away from the surgical site.
Catalog Number
C3601
Brand Name
CUSA® Excel
Version/Model Number
C3601
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
76b2f88a-4521-4ada-8247-4b732ca988be
Public Version Date
October 19, 2021
Public Version Number
5
DI Record Publish Date
December 29, 2016
Package DI Number
30381780025867
Quantity per Package
6
Contains DI Package
10381780025863
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 |