Identity
- Trade Name
- HarmonyAIR FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- The STERIS A-Series 4K Camera Module is used with the HarmonyAIR A-Series Lighting System. FDA UDI
- Model / Reference
- A-Series Camera FDA UDI
- Description
- The STERIS A-Series 4K Camera Module is used with the HarmonyAIR A-Series Lighting System. FDA UDI
Identifiers
- Catalog Number
- LAH00264K FDA UDI
- Primary DI / UDI-DI
- 00724995201227 FDA UDI
- FDA Product Code
- KQM FDA UDI
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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: Surgical video camera
HarmonyAIR by Steris Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI 94097fe3-9245-46cc-b19b-04627a047fcf 35 fields · synced Jun 8, 2026