Identity
- Trade Name
- daVinci Xi FDA UDI
- Generic Name
- Robotic surgical arm system FDA UDI
- Device Name
- SURGEON SIDE CONSOLE, RECERTIFIED FDA UDI
- Model / Reference
- 380798 FDA UDI
- Description
- SURGEON SIDE CONSOLE, RECERTIFIED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874115503 FDA UDI
- FDA Product Code
- NAY FDA UDI
- GMDN Term
- Robotic surgical arm system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Robotic surgical arm system
daVinci Xi by Intuitive Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Robotic surgical arm system.
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- ARTAS System — Venus Concept Inc. · Class II
- Adapter, Passive Allis Grasper, Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class I
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
- Intuitive Surgical, Inc.
Sources (1)
- FDA UDI d86ff22e-b615-4d48-8766-25dc336b132a 33 fields · synced Jun 9, 2026