CUSA® NXT

GUDID 10381780039471

Integra® CUSA NXT™

INTEGRA LIFESCIENCES (IRELAND) LIMITED

Soft-tissue ultrasonic surgical system handpiece tip, single-use

• Primary Device ID: 10381780039471
• NIH Device Record Key: 38ce0eb1-b912-429b-ad02-f5089d2c8db2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSA® NXT
• Version Model Number: NXT3219EA
• Company DUNS: 989925396
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780039471 [Primary]
HIBCC	M269NXT3219EA1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111741

FDA Product Code

• LFL: Instrument, ultrasonic surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-20
• Device Publish Date: 2017-01-27

On-Brand Devices [CUSA® NXT]

• 30381780040297: Tubing Kit - Box Of 10: The Selector tubing connects the handpiece to the IV fluid and connects
• 30381780040259: MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects
• 10381780039525: NXT Contamination Guard BOX2: The CUSA NXT Contamination Guard is fitted to the service module t
• M273NXT100011: The CUSA NXT footswitch is a device with two pedals used separately to control power and rate of
• M273CUSANXT21: The CUSA NXT service module houses the aspiration and irrigation subsystems controlled by the CU
• M273CUSANXT11: The CUSA NXT service module houses the aspiration and irrigation subsystems controlled by the CU
• M273CUSANXT1: The CUSA NXT console provides a touch screen interface for controlling the delivery of aspiratio
• 10381780039495: Integra® CUSA NXT™
• 10381780039471: Integra® CUSA NXT™
• M269NXT3218EA1: Integra® CUSA NXT™
• M273NXT800031: Integra® CUSA NXT™
• M273NXT800021: Integra® CUSA NXT™
• M273NXT800011: Integra® CUSA NXT™
• M610152324315: The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Select
• 30381780039482: The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that
• 30381780039468: The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that
• 30381780039444: The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that