AccessGUDID - DEVICE: CUSA® NXT (10381780039358)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® NXT
Version or Model: NXT10001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NXT10001
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780039358
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 Footswitch

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?
36336	Foot-switch, electrical	An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.	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: 6cm (2.4in) height x 19.5cm (7.7in) width x 22cm (8.7in) depth x 5.81m (19ft) length, 2kg (4.4lbs) weight

Device Record Status

Public Device Record Key: 7ad914e2-3051-4e45-87d9-f31ff25b3505
Public Version Date: October 28, 2024
Public Version Number: 6
DI Record Publish Date: December 29, 2016