Identity
- Trade Name
- Half-eye Trial Frame, rigid nose bridge FDA UDI
- Generic Name
- Trial lens frame FDA UDI
- Device Name
- Half-eye Trial Frame, rigid nose bridge FDA UDI
- Model / Reference
- 42580 FDA UDI
- Description
- Half-eye Trial Frame, rigid nose bridge FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584005823 FDA UDI
- FDA Product Code
- HPA FDA UDI
- GMDN Term
- Trial lens frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1415 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Trial lens frame
Half-eye Trial Frame, rigid nose bridge by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Trial lens frame.
- TF50 Trial Frame — REICHERT INC. · Class I
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- Retinoscopy rack with slider — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- Half-eye Trial Frame for children, rigid nose bridge — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- BK S1/W, wall version, trial lens case — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- BK S1/W, without convex cylinders, wall version, trial lens case — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- BK S1/T without convex cylinders, coated table version, trial lens case — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
- Half-eye Trial Frame, adjustable nose piece — OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung · Class I
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
Sources (1)
- FDA UDI b4b47bb5-9777-42c7-a122-12195b5a8da3 34 fields · synced May 30, 2026