Identity
- Trade Name
- Prism Lens Case, coated FDA UDI
- Generic Name
- Trial lens frame FDA UDI
- Device Name
- Prism Lens Case, coated FDA UDI
- Model / Reference
- 33106 FDA UDI
- Description
- Prism Lens Case, coated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584001078 FDA UDI
- FDA Product Code
- HPC FDA UDI
- GMDN Term
- Trial lens frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1405 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Prism Lens Case, coated by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — 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
Sources (1)
- FDA UDI e437ac1a-e7fa-4815-9349-b231245bd8ca 35 fields · synced May 29, 2026