Identity
- Trade Name
- Hayden Medical FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- Endoscopic Camera System and Light Source, Full HD 1080P Resolution with white balancing, zoom, and image capture. 2.3 Pro Camera head, 11 surgery modes, improved color, stroboscopic surgery Includes: Camera Head, Fiber Optic Light Cable FDA UDI
- Model / Reference
- 405-465CS FDA UDI
- Description
- Endoscopic Camera System and Light Source, Full HD 1080P Resolution with white balancing, zoom, and image capture. 2.3 Pro Camera head, 11 surgery modes, improved color, stroboscopic surgery Includes: Camera Head, Fiber Optic Light Cable FDA UDI
Identifiers
- Catalog Number
- 405-465CS FDA UDI
- Primary DI / UDI-DI
- 00840319757994 FDA UDI
- FDA Product Code
- FWF FDA UDI
- GMDN Term
- Endoscopic video image processing/light source system 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Endoscopic video image processing/light source system
Hayden Medical by Hayden Medical Inc — 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
- Hayden Medical Inc
Sources (1)
- FDA UDI 462d24d9-2fed-4fb8-9b05-14ee8c4455aa 35 fields · synced May 30, 2026