FDA UDI
In Commercial Distribution
🇺🇸 United States
Ocucyn Eyelid & Eyelash Cleanser
DI: 00850015491184
·
Model: 86002
·
Sonoma Pharmaceuticals, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ocucyn Eyelid & Eyelash Cleanser
- Primary DI
- 00850015491184
- Version / Model
- 86002
- Catalog Number
- 86002
- Company Name
- Sonoma Pharmaceuticals, Inc.
- Labeler DUNS
- 081642964
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- ab035278-433f-41e9-92e2-28d3f44f9ec2
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58837 | Eyelid solution | A fluid material intended to be applied to the eyelids for various therapeutic ocular applications that typically include provision of supplemental lipids on the eyelid margin to stabilize the natural tear film lipid layer in the treatment of tear film deficiencies (e.g., dry eye syndrome), or to clean the eyelid or eyelid margin in the treatment of blepharitis and/or meibomian gland dysfunction. It is typically a liposomal (e.g., phospholipid) suspension or a saline solution, and is intended for use in the home or healthcare facility (single dose or multidose). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850015491188 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00850015491184 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 40 | Milliliter |