FDA UDI
In Commercial Distribution
🇺🇸 United States
CLEAR CARE
DI: 00047113709338
·
Model: Clear Care 3oz
·
Alcon Laboratories, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CLEAR CARE
- Primary DI
- 00047113709338
- Version / Model
- Clear Care 3oz
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-02-25
- Public Version
- 1
- Public Version Date
- 2020-03-04
- Public Version Status
- New
- Public Device Record Key
- 3acd6b2c-a116-4128-b6b7-71c18979922c
Device Description
CLEAR CARE 3 oz
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| LPN | Accessories, soft lens products | Ophthalmic | 886.5928 | 2 |
| MRC | Products, contact lens care, rigid gas permeable | Ophthalmic | 886.5918 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48074 | Multi-purpose soft/rigid contact lens solution | A sterile aqueous formulation containing appropriate agents typically for cleaning, rinsing, protein removal, disinfecting, storing, and possibly wetting soft contact lenses and rigid gas permeable (RGP)/hard contact lenses. The solution may be specific to a type of procedure (e.g., manual, heated, or ultrasonic). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00047113709338 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]