Identity
- Trade Name
- ULTRAZYME FDA UDI
- Generic Name
- Contact lens protein-removal solution FDA UDI
- Device Name
- ULTRAZYME ENZYMATIC CLEANER 20 TABLETS FDA UDI
- Model / Reference
- 90278 FDA UDI
- Description
- ULTRAZYME ENZYMATIC CLEANER 20 TABLETS FDA UDI
Identifiers
- Catalog Number
- 90278 FDA UDI
- Primary DI / UDI-DI
- 00827444000157 FDA UDI
- FDA Product Code
- LPN FDA UDI
- GMDN Term
- Contact lens protein-removal 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 protein-removal solution
Ultrazyme by Johnson & Johnson Surgical Vision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Contact lens protein-removal solution.
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- OXYSEPT — Johnson & Johnson Surgical Vision, Inc. · 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
- Johnson & Johnson Surgical Vision, Inc.
Sources (1)
- FDA UDI b608731e-7787-4212-9ff4-622d5b1b6faf 35 fields · synced Jun 9, 2026