Synergeyes Casted Buttons
- Primary DI
- A50006
- Brand
- Synergeyes Casted Buttons
- Company
- SYNERGEYES, INC.
- Model
- paflufocon D – hem-iberfilcon A
- Device description
- Synergeyes paflufocon D – hem-iberfilcon A Casted Buttons
- Published
- 2017-09-14
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| HQD | Lens, Contact (Other Material) - Daily |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | Ophthalmic | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K052675 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| A50006 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Rigid-gas-permeable corrective contact lens, daily-wear | A 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. The lens may last for years and is a reusable device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 363381182
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| A50009 | SynergEyes casted button | petrafocon A hem-larafilcon A | 2017-09-14 |
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