AccessGUDID - DEVICE: CUSA® NXT (10381780039297)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® NXT
Version or Model: CUSANXT1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CUSANXT1
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780039297
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® NXT1 Service Module 115V

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?
37776	Ultrasonic suction system	An assembly of mains electricity (AC-powered) devices designed to use mechanical ultrasonic vibration and a combination of irrigation and suction to fragment and remove soft tissue and growths of high water content from various parts of the body. Ultrasonic suction units are used during neurosurgery, general surgery, and gynaecological and orthopaedic procedures.	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: Service Module 87.6cm (34.5 in) height x 50.3cm (19.8in) width x 76.6cm (28.6in) depth, 45.4kg (100lbs) weight

Device Record Status

Public Device Record Key: 5b4a3c37-3c19-469b-a3bd-69375702a73c
Public Version Date: October 28, 2024
Public Version Number: 7
DI Record Publish Date: December 29, 2016