Duns Number:989925396
Device Description: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirato The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator system and the CUSA Selector Integra Ultrasonic Surgical Aspirator system to facilitate the removal of tissue. The tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy and are non-sterile. The tips deliver the mechanical motion to ablate the tissues, then aspirate the waste fluid and suspended tissue pieces.
Catalog Number
1523066
Brand Name
CUSA® Selector®
Version/Model Number
1523066
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
K021989,K021989
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
d461b3ff-2cf9-4d5b-991e-8bab1f5b033b
Public Version Date
October 25, 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 |