FDA UDI
In Commercial Distribution
🇺🇸 United States
iLux
DI: 00380650005748
·
Model: 2022-PT
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- iLux
- Primary DI
- 00380650005748
- Version / Model
- 2022-PT
- Catalog Number
- 8065000574
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 51eda231-e1bc-4641-b4c3-a78f4d369778
Device Description
Systane iLux2 Meibography Tip
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
- 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 |
|---|---|---|---|---|
| ORZ | Eyelid Thermal Pulsation System | Ophthalmic | 886.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65304 | Meibomian gland image acquisition positioning-tip | A noninvasive, non-powered device intended to be attached to the distal end of a hand-held meibomian gland imaging unit (e.g., meibomian gland camera or eyelid thermal pulsation unit with integrated camera) to provide a stable point of contact with the patient’s face during acquisition of the image(s). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20380650005728 | GS1 | Box | 3 | In Commercial Distribution | |
| Primary | 00380650005748 | GS1 |