Identity
- Trade Name
- CUSA® Selector® FDA UDI
- Generic Name
- Ultrasonic surgical system torque wrench, single-use FDA UDI
- Device Name
- Only use the CUSA Selector wrench set to tighten and loosen tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece. The CUSA Selector Wrench Set is intended for use with Standard handpieces. FDA UDI
- Model / Reference
- 1523072M1 FDA UDI
- Description
- Only use the CUSA Selector wrench set to tighten and loosen tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece. The CUSA Selector Wrench Set is intended for use with Standard handpieces. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780040392 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
- 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
Category: Ultrasonic surgical system torque wrench, single-use
CUSA® Selector® by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic surgical system torque wrench, single-use.
- CUSA® Clarity — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Clarity — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Excel — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Clarity — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Excel — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
- CUSA® Clarity — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
Cleared under the same submission
K021989 also covers:
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED
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 b2dfe1da-5fcf-4ec2-9b33-57a49672bb51 36 fields · synced May 30, 2026