Identity
- Trade Name
- CUSA® Excel EUDAMEDFDA UDIIntegra® FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDIElectrical-only medical device connection cable, reusable FDA UDI
- Device Name
- lntegra Monitor cables EUDAMEDCUSA® Excel 36kHz 1.14mm PrecisionTip™ Curved Extended Tip FDA UDIIntegra® Monitor Adaptor Cable, Intracranial Pressure FDA UDI
- Model / Reference
- ICP-39 EUDAMEDFDA UDIC4608S FDA UDI
- Description
- CUSA® Excel 36kHz 1.14mm PrecisionTip™ Curved Extended Tip FDA UDIIntegra® Monitor Adaptor Cable, Intracranial Pressure FDA UDI
Identifiers
- Catalog Number
- C4608S FDA UDIICP-39 FDA UDI
- Primary DI / UDI-DI
- 10381780039730 EUDAMEDFDA UDI10381780025993 FDA UDI
- Basic UDI-DI
- 038178B0036CSS3D EUDAMED
- Direct Marketing DI
- 10381780039730 EUDAMED
- FDA Product Code
- LFL FDA UDIGWM FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDIElectrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDIClass II FDA UDI
- Regulation Number
- 882.1620 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Excel by Integra Lifesciences (ireland) Limited — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences (ireland) Limited
Sources (3)
- FDA UDI 273ea73c-19a9-478e-8f8a-e0b90be8cfe7 37 fields · synced Oct 6, 2026
- FDA UDI 8d737b54-80aa-40e4-a4df-73ea8c92201b 36 fields · synced May 30, 2026
- EUDAMED a713126b-3d2d-482c-b7c5-1d95d7817662 61 fields · synced Sep 17, 2026