CUSA® Selector®

GUDID 10381780040408

Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.

INTEGRA LIFESCIENCES (IRELAND) LIMITED

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Primary Device ID	10381780040408
NIH Device Record Key	d41c97a1-ca65-4e82-ab56-8e7d0a7aae3e
Commercial Distribution Discontinuation	2023-12-04
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	CUSA® Selector®
Version Model Number	1523072M2
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.
Special Storage Condition, Specify	Between 0 and 0 *Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780040408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K021989

FDA Product Code

LFL	Instrument, ultrasonic surgical