Identity
- Trade Name
- REAL INTELLIGENCE FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- REAL INTELLIGENCE TUBING SET FDA UDI
- Model / Reference
- ROB10031 FDA UDI
- Description
- REAL INTELLIGENCE TUBING SET FDA UDI
Identifiers
- Catalog Number
- ROB10031 FDA UDI
- Primary DI / UDI-DI
- 00885556757468 FDA UDI
- 510(k) Number
- K193120 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical irrigation/aspiration tubing set 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
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
No
FDA UDI
Category: Surgical irrigation/aspiration tubing set
Real Intelligence by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical irrigation/aspiration tubing set.
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI c2fccda5-43cc-4e9b-bc9a-92168b518e8f 36 fields · synced Jun 8, 2026