Identity
- Trade Name
- SYSTANE FDA UDI
- Generic Name
- Contact lens wetting solution FDA UDI
- Device Name
- SYSTANE Contacts Lubricant Eye Drops 12ml FDA UDI
- Model / Reference
- SYSTANE 12ml FDA UDI
- Description
- SYSTANE Contacts Lubricant Eye Drops 12ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00300650190930 FDA UDI
- FDA Product Code
- LPN FDA UDI
- GMDN Term
- Contact lens wetting solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5928 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Contact lens wetting solutionEye lubricant
Systane by Alcon Laboratories, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Eye lubricant.
- Clear Eyes® — MEDTECH PRODUCTS, INC. · Class II
- REFRESH RELIEVA FOR CONTACTS — Allergan · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (2)
- FDA UDI 49805c8b-2be9-4979-851a-bc4a60862a72 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026