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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 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (Emerald, oprifocon A, Green) FDA UDI
- Model / Reference
- Emerald FDA UDI
- Description
- Kit containing 850007135003 (Emerald, oprifocon A, Blue) and 850007135010 (Emerald, oprifocon A, Green) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850007135994 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
- 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
Category: Orthokeratology contact lens
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear by Euclid Vision Corporation — Class III — FDA UDI — listed in FDA GUDID
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Also classified as Orthokeratology contact lens.
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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 III | Pending data |
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Manufacturer
- Manufacturer
- Euclid Vision Corporation
Sources (1)
- FDA UDI 1886f184-cb60-46e7-9e87-6c8c20bfe50c 34 fields · synced Jun 1, 2026