Identity
- Trade Name
- CUSA® NXT FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console. FDA UDI
- Model / Reference
- 1532024 FDA UDI
- Description
- MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780040255 FDA UDI
- 510(k) Number
- K081459 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set 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
Yes
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
Cleared under the same submission
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 f8a9d94f-bf95-4952-80b6-8099cfcbc721 37 fields · synced Jun 8, 2026