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CUSA® Excel

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name
CUSA® Excel FDA UDI
Generic Name
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Device Name
CUSA® Excel CUSA® SaberTip™ 36kHz, 1.14mm FDA UDI
Model / Reference
C4616S FDA UDI
Description
CUSA® Excel CUSA® SaberTip™ 36kHz, 1.14mm FDA UDI

Identifiers

Catalog Number
C4616S FDA UDI
Primary DI / UDI-DI
10381780026075 FDA UDI
FDA Product Code
LBK FDA UDI
LFL FDA UDI
GMDN Term
Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

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

Similar devices

Also classified as Soft-tissue ultrasonic surgical system handpiece tip, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences (ireland) Limited

Sources (1)

  • FDA UDI 16da4fe7-7cae-485d-95c0-5a356df68bcf 37 fields · synced Jun 8, 2026