Identity
- Trade Name
- Humphrey FDT FDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine the amount of visual field loss in a patient, which can then be used to diagnose/track the progression of glaucoma and other eye diseases. FDA UDI
- Model / Reference
- 710 FDA UDI
- Description
- Humphrey FDT is an AC-powered device intended to determine the extent of the peripheral visual field of a patient. The device is intended to determine the amount of visual field loss in a patient, which can then be used to diagnose/track the progression of glaucoma and other eye diseases. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04057748085215 FDA UDI
- FDA Product Code
- HOO FDA UDI
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1605 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Humphrey FDT by Carl Zeiss Meditec AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 92630dd0-2fd2-4f9e-ae55-4b31605205f2 34 fields · synced Jun 8, 2026