FDA UDI
In Commercial Distribution
🇺🇸 United States
ZonedIn Contact Lenses
DI: 00810040141645
·
Model: 510100
·
ZONEDIN VISION, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZonedIn Contact Lenses
- Primary DI
- 00810040141645
- Version / Model
- 510100
- Catalog Number
- 510100
- Company Name
- ZONEDIN VISION, LLC
- Labeler DUNS
- 117142079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-04
- Public Version
- 1
- Public Version Date
- 2019-12-12
- Public Version Status
- New
- Public Device Record Key
- 266d561c-4fdb-45d3-bcd8-575a87a313d4
Device Description
Daily wear soft contact lens trial -1.00 power
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVN | Lens, contact, (disposable) | Ophthalmic | 886.5925 | 2 |
| LPL | Lenses, soft contact, daily wear | Ophthalmic | 886.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47841 | Soft corrective contact lens, daily-disposable | A soft ophthalmic lens intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct refractive vision conditions (e.g., myopia, hyperopia, astigmatism, presbyopia); it is designed to be discarded each day after removal. The device may be coloured/tinted for easier handling or to change the appearance of the eye for cosmetic purposes; it may include an ultraviolet blocker. The device is made of various synthetic polymer materials, the main polymer molecules being hydrophilic (e.g., hydrogel); it permits diffusion of oxygen (O2) to the ocular surface. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810040141645 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083288 | 000 |