Identity
- Trade Name
- REAL INTELLIGENCE FDA UDI
- Generic Name
- Optical surgical navigation device tracking system workstation, mobile FDA UDI
- Device Name
- REAL INTELLIGENCE ROBOTICS CART BASE 220 FDA UDI
- Model / Reference
- ROB100022 FDA UDI
- Description
- REAL INTELLIGENCE ROBOTICS CART BASE 220 FDA UDI
Identifiers
- Catalog Number
- ROB100022 FDA UDI
- Primary DI / UDI-DI
- 00885556774151 FDA UDI
- 510(k) Number
- K193120 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Optical surgical navigation device tracking system workstation, mobile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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: Optical surgical navigation device tracking system workstation, mobile
Real Intelligence by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical surgical navigation device tracking system workstation, mobile.
- ENVISION 3D: LIGHT HANDLE — 7D Surgical ULC · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
- Op.n Core — ECENTIAL ROBOTICS · Class II
- 7D Surgical System — 7D Surgical ULC · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
- ENVISION 3D: IMAGE GUIDANCE SYSTEM — 7D Surgical ULC · Class II
- Clear Guide CORE — Clear Guide Medical · Class II
Cleared under the same submission
K193120 also covers:
- CORI — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
- REAL INTELLIGENCE — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 31f8535f-1295-416c-87f3-f1672b4d1ae2 36 fields · synced Jun 8, 2026