AccessGUDID - DEVICE: CUSA® NXT (10381780039280)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® NXT
Version or Model: CUSANXT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CUSANXT
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780039280
Issuing Agency: GS1
Commercial Distribution End Date: September 03, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA® NXT Console

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, ultrasonic surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: +25% to +85%. Atmospheric Pressure: +500hPa to +1100hPa. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Console 31.08cm(12.5in)height, 45.7cm(18in)width, 58.9cm(23.2in)depth, 20.9kg (46lbs)weight; Footswitch 6cm(2.4in)height, 19.5cm (7.7in)width, 22cm (8.7in)depth, 5.81m(19ft)length, 2kg(4.4lbs)weight

Device Record Status

Public Device Record Key: 8fe9d9de-bbc4-4c9c-8391-e8eafd079f7b
Public Version Date: October 28, 2024
Public Version Number: 7
DI Record Publish Date: December 29, 2016