Identity
- Trade Name
- CUSA® NXT FDA UDI
- Generic Name
- Electrical mains power cable FDA UDI
- Device Name
- Integra® CUSA NXT™ FDA UDI
- Model / Reference
- NXT80002 FDA UDI
- Description
- Integra® CUSA NXT™ FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780039372 FDA UDI
- 510(k) Number
- K081459 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Electrical mains power cable 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: Electrical mains power cable
Cusa® Nxt by Integra Lifesciences (ireland) Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081459 also covers:
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 f22156dc-c0d8-44d7-a600-e3bc9d97f2ae 37 fields · synced May 30, 2026