FDA UDI
In Commercial Distribution
🇺🇸 United States
Custom Stable
DI: 00860011844129
·
Model: Optimum Extreme (roflufocon E) Light Blue
·
Valley Contax, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Custom Stable
- Primary DI
- 00860011844129
- Version / Model
- Optimum Extreme (roflufocon E) Light Blue
- Company Name
- Valley Contax, Inc.
- Labeler DUNS
- 013969530
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-14
- Public Version
- 2
- Public Version Date
- 2026-03-17
- Public Version Status
- Update
- Public Device Record Key
- 868f1d30-761c-4a7b-b883-0d5e8bb26f8b
Device Description
Custom Stable Specialty Scleral Contact Lens for Daily Wear, made in Optimum Extreme Light Blue material
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 |
|---|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | Ophthalmic | 886.5916 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47840 | Rigid-gas-permeable corrective contact lens, daily-wear, non-customized | A prefabricated (non-customized) rigid ophthalmic lens intended to be worn directly against the cornea of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be removed prior to sleeping each night. 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 | 00860011844129 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213880 | 000 |