Identity
- Trade Name
- CUSA® NXT FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
- Device Name
- The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and Reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery. FDA UDI
- Model / Reference
- 1523243 FDA UDI
- Description
- The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and Reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780039501 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
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 3586acf1-c8d3-4b78-b1a9-b50236af54fe 37 fields · synced Jun 1, 2026