FDA UDI
In Commercial Distribution
🇺🇸 United States
Sophisticated Kristin Monthly
DI: 08800071415190
·
Model: Sophisticated Kristin Monthly
·
DK MEDIVISION Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Sophisticated Kristin Monthly
- Primary DI
- 08800071415190
- Version / Model
- Sophisticated Kristin Monthly
- Company Name
- DK MEDIVISION Co.,Ltd.
- Labeler DUNS
- 688303758
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-06-09
- Public Version
- 1
- Public Version Date
- 2025-06-17
- Public Version Status
- New
- Public Device Record Key
- 917de7f4-49fb-40de-8586-cf66eb136c53
Device Description
Sophisticated Kristin Monthly/Olive Color/-0.50/100EA
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | Ophthalmic | 886.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47842 | Soft corrective contact lens, daily-wear | 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 that occur naturally (e.g., myopia, hyperopia, astigmatism, presbyopia) or post surgery; it is designed to be removed prior to sleeping each night. 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08800071420316 | GS1 | ||||
| Primary | 08800071415190 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K220045 | 000 |