CUSA® Selector®

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name: CUSA® Selector® FDA UDI
Generic Name: Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Device Name: The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic. FDA UDI
Model / Reference: 1523235 FDA UDI
Description: The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780040361 FDA UDI
FDA Product Code: LFL FDA UDI
GMDN Term: Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

CUSA® Selector® by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Integra Lifesciences (ireland) Limited

Sources (1)

FDA UDI 54c48209-c6ac-4181-8f9b-0745dce99734 37 fields · synced May 31, 2026