Identity
- Trade Name
- CUSA® NXT FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- CUSA® NXT Contamination Guard FDA UDI
- Model / Reference
- NXT00005 FDA UDI
- Description
- CUSA® NXT Contamination Guard FDA UDI
Identifiers
- Catalog Number
- NXT00005 FDA UDI
- Primary DI / UDI-DI
- 10381780039525 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system 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
Cusa® Nxt by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 4a9fe769-7b33-4ed3-80c7-f0e080f9ceee 37 fields · synced May 30, 2026