Identity
- Trade Name
- Menicon Unique pH Multi-Purpose Solution FDA UDI
- Generic Name
- Multi-purpose rigid contact lens solution FDA UDI
- Model / Reference
- Starter Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853253003058 FDA UDI
- 510(k) Number
- K130805 FDA UDI
- FDA Product Code
- MRC FDA UDI
- GMDN Term
- Multi-purpose rigid contact lens solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5918 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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: Multi-purpose rigid contact lens solution
Menicon Unique pH Multi-Purpose Solution by Menicon America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multi-purpose rigid contact lens solution.
- Equate — Walmart Stores · Class II
- Equate — Walmart Stores · Class II
- Vista Clean Multi-Purpose Solution — Nomax, Inc. · Class II
- Tangible Clean 3-pack — TANGIBLE SCIENCE Inc · Class II
- up & up rigid gas permeable contact lens conditioning solution — TARGET CORPORATION · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Tangible Clean Sample Bottle — TANGIBLE SCIENCE Inc · Class II
- Tangible Clean — TANGIBLE SCIENCE Inc · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Menicon America, Inc.
Sources (1)
- FDA UDI 958c80aa-a8da-4bfe-8047-315fe3ca04b7 33 fields · synced Jun 6, 2026