Identity
- Trade Name
- HarmonyAIR FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- The A-Series High Density Dual Light with ConnectPoint 51-inch ConnectPoint, 43-inch Light, 35.5-inch Light, No Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System. FDA UDI
- Model / Reference
- A-Series Lighting System FDA UDI
- Description
- The A-Series High Density Dual Light with ConnectPoint 51-inch ConnectPoint, 43-inch Light, 35.5-inch Light, No Drop Tube, Tandem is used with the HarmonyAIR A-Series Lighting System. FDA UDI
Identifiers
- Catalog Number
- LAH10INNDT FDA UDI
- Primary DI / UDI-DI
- 00724995186982 FDA UDI
- FDA Product Code
- FSY FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Operating room light systemOperating room lightMedical monitor/light mount
The HarmonyAIR device is a high-density dual light system used in operating rooms to provide precise and focused lighting for surgical procedures. With its advanced features, including ConnectPoint technology and dual halogen bulbs, this device offers unparalleled illumination and safety.
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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
- Steris Corporation
Sources (1)
- FDA UDI 291a213b-854e-4ef6-a04c-fe3b4c38144c 35 fields · synced Jun 25, 2026