Identity
- Trade Name
- OPTI-FREE REPLENISH FDA UDI
- Generic Name
- Contact lens wetting solution FDA UDI
- Device Name
- OPTI-FREE REPLENISH Rewetting Drops 10ml FDA UDI
- Model / Reference
- OPTI-FREE REPLENISH 10ml FDA UDI
- Description
- OPTI-FREE REPLENISH Rewetting Drops 10ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00300650192293 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 solution
Opti-Free Replenish by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- BLINK CONTACTS — Johnson & Johnson Surgical Vision, Inc. · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Biotrue® Hydration Boost Contact Lens Rehydrating Drops — Bausch & Lomb Incorporated · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (1)
- FDA UDI 13a520bb-5026-4599-88b8-099d1b817d13 34 fields · synced May 30, 2026