Integra® CUSA NXT™

GUDID 10381780039518

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: 10381780039518
• NIH Device Record Key: 1382fb03-ced7-46e5-be33-f166645b1a96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra® CUSA NXT™
• Version Model Number: 1523243EA
• 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: 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
• 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

Device Dimensions

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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%.
• 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%.
• 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	10381780039518 [Primary]
HIBCC	M6101523243EA1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102258

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: 2022-12-06
• Device Publish Date: 2017-01-27

Devices Manufactured by INTEGRA LIFESCIENCES (IRELAND) LIMITED

• 30381780039444 - CUSA® NXT: 2024-11-20 The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgica
• 30381780039468 - CUSA® NXT: 2024-11-20 The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgica
• 30381780039482 - CUSA® NXT: 2024-11-20 The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgica
• 30381780040365 - CUSA® Selector®: 2024-11-20 The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from ti
• 30381780121972 - CUSA® Selector®: 2024-11-20 The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from ti
• M610152324315 - CUSA® NXT: 2024-10-28 The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator
• 10381780040712 - CUSA® Selector®: 2024-10-28 Neurosurgical Long Extension Shroud: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Sh
• 10381780040408 - CUSA® Selector®: 2024-03-18 Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench