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CUSA® Selector®

FDA UDI

Class U (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name
CUSA® Selector® FDA UDI
Generic Name
Ultrasonic surgical system torque wrench, single-use FDA UDI
Device Name
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. FDA UDI
Model / Reference
1523072M2 FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
10381780040408 FDA UDI
510(k) Number
K021989 FDA UDI
FDA Product Code
LFL FDA UDI
GMDN Term
Ultrasonic surgical system torque wrench, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Cleared under the same submission

K021989 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 d41c97a1-ca65-4e82-ab56-8e7d0a7aae3e 37 fields · synced Jun 1, 2026