Identity
- Trade Name
- Menicon Progent Protein Remover FDA UDI
- Generic Name
- Contact lens protein-removal solution FDA UDI
- Model / Reference
- 1P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853253003034 FDA UDI
- 510(k) Number
- K122273 FDA UDI
- FDA Product Code
- MRC FDA UDI
- GMDN Term
- Contact lens protein-removal 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: Contact lens protein-removal solution
Menicon Progent Protein Remover by Menicon America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Contact lens protein-removal solution.
- OXYSEPT — Johnson & Johnson Surgical Vision, Inc. · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- ULTRAZYME — Johnson & Johnson Surgical Vision, Inc. · Class II
- Menicon Progent Protein Remover — MENICON AMERICA, INC. · Class II
Cleared under the same submission
K122273 also covers:
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
- Menicon America, Inc.
Sources (1)
- FDA UDI 1a11f5d7-69ff-49f3-a260-4bfa36b906bf 33 fields · synced May 30, 2026