FDA UDI
In Commercial Distribution
🇺🇸 United States
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
DI: 85000713501512
·
Model: CHN010-11-P2
·
Euclid Vision Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear
- Primary DI
- 85000713501512
- Version / Model
- CHN010-11-P2
- Catalog Number
- Emerald Toric
- Company Name
- Euclid Vision Corporation
- Labeler DUNS
- 969263979
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-05
- Public Version
- 1
- Public Version Date
- 2026-02-13
- Public Version Status
- New
- Public Device Record Key
- 26c3b7b8-8aaf-49ef-83e3-7da01297ee4a
Device Description
Kit containing 2x 00850007135058 (Emerald Toric, oprifocon A, Blue) China Distribution
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUU | Lens, Contact, Orthokeratology, Overnight | Ophthalmic | 886.5916 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47926 | Orthokeratology contact lens | A rigid-gas-permeable ophthalmic lens intended to be worn directly against the cornea of the eye for orthokeratology (Ortho-K), a procedure where the lens is worn for several hours, typically each night, to modify the curvature of the cornea as an alternative method to correct refractive vision conditions. The device is made of various materials (e.g., cellulose acetate butyrate, polyacrylate-silicone, silicone elastomers) whose main polymer molecules generally do not absorb or attract water but permit diffusion of oxygen (O2) to the ocular surface. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 85000713501512 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P040029 | 000 |