Duns Number:989925396
Device Description: Excel Contamination Guard BOX2: The Contamination Guard is compatible with the CUSA® Excel Excel Contamination Guard BOX2: The Contamination Guard is compatible with the CUSA® Excel family of Ultrasonic Surgical Aspirator systems. The CUSA Excel Contamination Guard is a mechanical shut off valve that prevents liquids and aspirated tissue from reaching the vacuum pump. The Contamination Guard packing contains two (2) individual, non-sterile, Contamination Guards. The Contamination Guard is sold non-sterile. The contamination guard will be changed at maximum every six months or sooner if necessary.
Catalog Number
C0005
Brand Name
CUSA® Excel
Version/Model Number
C0005
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)
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
6f409b18-ad30-40e6-9f25-4fb66c951eed
Public Version Date
October 26, 2022
Public Version Number
5
DI Record Publish Date
December 29, 2016
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 95 |
| U | Unclassified | 114 |