Identity
- Trade Name
- JEDMED FDA UDI
- Generic Name
- Direct ophthalmoscope FDA UDI
- Device Name
- Ophthalmoscope Lens 45-Deg Series 2 FDA UDI
- Model / Reference
- 39-7428-2 FDA UDI
- Description
- Ophthalmoscope Lens 45-Deg Series 2 FDA UDI
Identifiers
- Catalog Number
- 39-7428-2 FDA UDI
- Primary DI / UDI-DI
- M63339742820 FDA UDI
- FDA Product Code
- HLI FDA UDI
- GMDN Term
- Direct ophthalmoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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: Direct ophthalmoscope
Jedmed by JEDMED Instrument Company — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- JEDMED Instrument Company
Sources (1)
- FDA UDI 2f9e3ba7-b5b0-406b-bf90-18d7fe56a6d3 35 fields · synced May 30, 2026