Duns Number:989925396
Device Description: The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator Syste The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
Catalog Number
-
Brand Name
CUSA® NXT
Version/Model Number
NXT3218
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
K111741,K111741
Product Code
LFL
Product Code Name
Instrument, ultrasonic surgical
Public Device Record Key
71b26925-2315-4a11-be69-5cf4bc084f97
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 29, 2016
Package DI Number
30381780039444
Quantity per Package
5
Contains DI Package
10381780039440
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 |