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Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear FDA UDI
- Generic Name
- Orthokeratology contact lens FDA UDI
- Device Name
- Kit containing 00850007135027 (Emerald, oprifocon A, Blue) and 00850007135034 (Emerald, oprifocon A, Green) FDA UDI
- Model / Reference
- Emerald FDA UDI
- Description
- Kit containing 00850007135027 (Emerald, oprifocon A, Blue) and 00850007135034 (Emerald, oprifocon A, Green) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 85000713500218 FDA UDI
- FDA Product Code
- NUU FDA UDI
- GMDN Term
- Orthokeratology contact lens FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 886.5916 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear by Euclid Vision Corporation — Class III — FDA UDI — listed in FDA GUDID
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 III | Pending data |
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Manufacturer
- Manufacturer
- Euclid Vision Corporation
Sources (1)
- FDA UDI f398573d-3514-48cb-9ca1-87f6486dd1ec 35 fields · synced May 29, 2026