CUSA® Selector® 1523216

GUDID 30381780177672

24kHz Selector SaberTip (5 pack): The Selector SaberTip is designed specifically to selectively remove hard tissue suchh as bone. It has an abrasive surface that is oriented superiorly at the distal end of tip. The abrasive surface covers only the top 180 degree of the tip and faces.

INTEGRA LIFESCIENCES (IRELAND) LIMITED

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

• Primary Device ID: 30381780177672
• NIH Device Record Key: c3810816-54c8-49ea-8d0c-b467456fa4df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CUSA® Selector®
• Version Model Number: 1523216
• Catalog Number: 1523216
• 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
• 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
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• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780177678 [Primary]
GS1	30381780177672 [Package]; Contains: 10381780177678; Package: BOX [5 Units]; In Commercial Distribution
HIBCC	M26915232161 [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: 2022-10-25
• 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