Identity
- Trade Name
- INTELLIO Tablet FDA UDI
- Generic Name
- Operating room audiovisual data/device management system application software FDA UDI
- Device Name
- INTELLIO TABLET FDA UDI
- Model / Reference
- 72205455 FDA UDI
- Description
- INTELLIO TABLET FDA UDI
Identifiers
- Catalog Number
- 72205455 FDA UDI
- Primary DI / UDI-DI
- 00885556813683 FDA UDI
- 510(k) Number
- K221929 FDA UDI
- FDA Product Code
- ODA FDA UDI
- GMDN Term
- Operating room audiovisual data/device management system application software 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: Operating room audiovisual data/device management system application software
INTELLIO Tablet by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Operating room audiovisual data/device management system application software.
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- VISIUSmatrix — IMRIS Imaging, Inc. · Class I
- KARL STORZ AIDA — Karl Storz GmbH & Co. KG · Class II
- Connected OR OS — Stryker Corp. · Class II
- SONY — SONY CORPORATION · Class II
Cleared under the same submission
K221929 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 14b74acc-f3ae-4fe8-963d-e2448795eecf 36 fields · synced Jun 6, 2026