CUSA® NXT

GUDID M610152324315

The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are 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/Thoracoscopic surgery.

INTEGRA LIFESCIENCES (IRELAND) LIMITED

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

• Primary Device ID: M610152324315
• NIH Device Record Key: 3586acf1-c8d3-4b78-b1a9-b50236af54fe
• Commercial Distribution Discontinuation: 2024-09-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CUSA® NXT
• Version Model Number: 1523243
• Company DUNS: 989925396
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Device Count: 5
• 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: false
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.
• Special Storage Condition, Specify: Between 0 and 0 *Temperature -29°C to 60°C ; Relative Humidity non condensing 30% to 85%.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780039504 [Unit of Use]
GS1	10381780039501 [Primary]
HIBCC	M610152324315 [Secondary]

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: 2024-10-28
• Device Publish Date: 2016-12-29

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