Duns Number:989925396
Device Description: Angled Extension Shroud: The shrouds are intended to direct the saline irrigation fluid to Angled Extension Shroud: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud Black heat resistant shrouds that are interconnected by snap-in push fittings with the exception of the laparoscopic handpiece which has a screw thread joint. The shrouds cover one or two titanium alloy parts. All handpieces contain a tip. Angled handpieces also include an angled extension.
Catalog Number
1523035
Brand Name
CUSA® Selector®
Version/Model Number
1523035
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
K021989
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
c826ce27-2894-40b5-b5b9-d87910446403
Public Version Date
October 26, 2022
Public Version Number
4
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 |