Identity
- Trade Name
- CUSA® Excel FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece tip, reusable FDA UDI
- Device Name
- CUSA® Excel CUSA® Excel 23KHz 1.98mm Extended Life Laparoscopic Tip FDA UDI
- Model / Reference
- C4604ELT FDA UDI
- Description
- CUSA® Excel CUSA® Excel 23KHz 1.98mm Extended Life Laparoscopic Tip FDA UDI
Identifiers
- Catalog Number
- C4604ELT FDA UDI
- Primary DI / UDI-DI
- 10381780025931 FDA UDI
- FDA Product Code
- LFL FDA UDILBK FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece tip, reusable 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Soft-tissue ultrasonic surgical system handpiece tip, reusable
CUSA® Excel by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Soft-tissue ultrasonic surgical system handpiece tip, reusable.
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- CUSA® Selector® — INTEGRA LIFESCIENCES (IRELAND) LIMITED · U
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 b7357e48-d01f-4193-8857-644065ffedf3 37 fields · synced May 31, 2026