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CUSA® Clarity

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name
CUSA® Clarity FDA UDI
Generic Name
Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
Device Name
CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack) FDA UDI
Model / Reference
C7421SEA FDA UDI
Description
CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack) FDA UDI

Identifiers

Catalog Number
C7421SEA FDA UDI
Primary DI / UDI-DI
10381780536352 FDA UDI
510(k) Number
K221835 FDA UDI
FDA Product Code
LBK FDA UDI
LFL FDA UDI
GMDN Term
Hard-tissue ultrasonic surgical system handpiece tip 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
MRI Safety
MR Unsafe FDA UDI

Category: Hard-tissue ultrasonic surgical system handpiece tip

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

Similar devices

Also classified as Hard-tissue ultrasonic surgical system handpiece tip.

Cleared under the same submission

K221835 also covers:

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 47e88327-f077-4080-8f81-643463a04706 37 fields · synced Jun 8, 2026