Identity
- Trade Name
- Nexxis FDA UDI
- Generic Name
- Operating room audiovisual data/device management system FDA UDI
- Device Name
- NEXXIS SYSTEM ST KIT 2 FDA UDI
- Model / Reference
- NEXXIS SYSTEM ST KIT 2 FDA UDI
- Description
- NEXXIS SYSTEM ST KIT 2 FDA UDI
Identifiers
- Catalog Number
- K9605013 FDA UDI
- Primary DI / UDI-DI
- 05415334002081 FDA UDI
- FDA Product Code
- DXJ FDA UDI
- GMDN Term
- Operating room audiovisual data/device management system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2450 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Nexxis by Barco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K122167 also covers:
K170537 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 II | Pending data |
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Manufacturer
- Manufacturer
- Barco, Inc.
Sources (1)
- FDA UDI bb769dc1-4ac1-4aee-9545-b54950683d8d 37 fields · synced Jun 1, 2026