FDA UDI
In Commercial Distribution
🇺🇸 United States
OPTI-FREE
DI: 00300650180023
·
Model: OPTI-FREE LENS CASE
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OPTI-FREE
- Primary DI
- 00300650180023
- Version / Model
- OPTI-FREE LENS CASE
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-01-24
- Public Version Status
- Update
- Public Device Record Key
- c7a15f23-2d35-4a9b-93d0-0051f84b9506
Device Description
OPTI-FREE LENS CASE
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRX | Case, contact lens | Ophthalmic | 886.5928 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16581 | Contact lens case | A container, typically made of plastic, designed for the storage of contact lenses when the lenses are not being used by the owner. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00300650180023 | GS1 | ||||
| Package | 00300650180047 | GS1 | Case | 24 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)241-5999
- [email protected]