Duns Number:989925396
Device Description: The Tips are machined hollow tubes with fittings at the distal end which connect to the ha The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
Catalog Number
-
Brand Name
CUSA® NXT
Version/Model Number
1529165
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
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
K081459,K081459
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
4bb9d3d8-f802-4bc6-b5b6-ae17c0ccfa06
Public Version Date
August 21, 2018
Public Version Number
4
DI Record Publish Date
January 27, 2017
Package DI Number
30381780122009
Quantity per Package
5
Contains DI Package
10381780122005
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 |