Identity
- Trade Name
- Connected OR Hub FDA UDI
- Generic Name
- Operating room audiovisual data/device management system FDA UDI
- Model / Reference
- 0240200200 FDA UDI
Identifiers
- Catalog Number
- 0240-200-200 FDA UDI
- Primary DI / UDI-DI
- 07613327601695 FDA UDI
- 510(k) Number
- K241401 FDA UDI
- FDA Product Code
- GCJ FDA UDIHRX FDA UDI
- GMDN Term
- Operating room audiovisual data/device management system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI888.1100 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
Connected OR Hub by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating room audiovisual data/device management system.
- Nexxis OR — Barco, Inc. · Class II
- Nexxis OR — Barco, Inc. · Class II
- AIDA connect — Karl Storz GmbH & Co. KG · Class II
- AIDA connect — Karl Storz GmbH & Co. KG · Class II
- VISIUSmatrix — IMRIS Imaging, Inc. · Class I
- CALLISTO eye — Carl Zeiss Meditec AG · Class II
- Nexxis OR — Barco, Inc. · Class II
- VISIUSmatrix — IMRIS Imaging, Inc. · Class I
Cleared under the same submission
K241401 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
- Stryker Corp.
Sources (1)
- FDA UDI 1d16cf25-be6d-48f3-afa3-a102a35625cb 35 fields · synced May 30, 2026