CUSA® Selector®

GUDID 30381780040242

Microsurgical - Box Of 10: The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console.

INTEGRA LIFESCIENCES (IRELAND) LIMITED

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

• Primary Device ID: 30381780040242
• NIH Device Record Key: 33d13cd4-d2cc-484b-acc6-31b8293df701
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSA® Selector®
• Version Model Number: 1529036
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780040248 [Primary]
GS1	30381780040242 [Package]; Contains: 10381780040248; Package: BOX [10 Units]; In Commercial Distribution
HIBCC	M26915290361 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081459

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

On-Brand Devices [CUSA® Selector®]

• 10381780121947: SELECTOR HANDPIECE STERILIZATION TRAY:The steriliser tray provides a convenient handling system
• 30381780177672: 24kHz Selector SaberTip (5 pack): The Selector SaberTip is designed specifically to selectively
• M27315230421: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• M27315290141: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• M27315230661: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230671: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230561: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230641: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230131: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• 10381780040330: This brush is used for cleaning the aspiration channel of the handpiece which is supplied with e
• 10381780040071: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040064: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040057: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040040: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040033: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040026: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040019: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780040002: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780039990: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780039983: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780039976: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780039969: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780039952: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• 10381780039945: The CUSA Selector handpiece is a handheld surgical device. It houses a piezoelectric transducer
• M27315231621: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• M27315230471: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• M27315230461: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• 10381780121909: Angled Extension Shroud: The shrouds are intended to direct the saline irrigation fluid to the s
• M27315230321: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• M27315230431: The CUSA Selector Flues are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator sys
• M27315290661: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315290641: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315290651: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230781: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230771: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315290631: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230161: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230141: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• M27315230151: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• 10381780040224: Extensions are intended to direct the saline irrigation solution to the target tissue. Only use
• 10381780040217: Extensions are intended to direct the saline irrigation solution to the target tissue. Only use
• 10381780040200: Extensions are intended to direct the saline irrigation solution to the target tissue. Only use
• 10381780040194: Extensions are intended to direct the saline irrigation solution to the target tissue. Only use
• 10381780040187: Extensions are intended to direct the saline irrigation solution to the target tissue. Only use
• 10381780040170: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud
• M27315230291: The CUSA Selector tips are intended for use with the CUSA NXT Ultrasonic Surgical Aspirator syst
• 10381780040156: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud
• 10381780040149: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud
• 10381780040132: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud
• 10381780040118: The shrouds are intended to direct the saline irrigation fluid to the site of operation. Shroud