Identity
- Trade Name
- Verisyse FDA UDI
- Generic Name
- Anterior-chamber intraocular lens, phakic FDA UDI
- Device Name
- Verisyse Myopia 5.0 mm -11.5D FDA UDI
- Model / Reference
- VRSM5US FDA UDI
- Description
- Verisyse Myopia 5.0 mm -11.5D FDA UDI
Identifiers
- Catalog Number
- VRSM5US -11.5D FDA UDI
- Primary DI / UDI-DI
- 08717819047448 FDA UDI
- PMA Number
- P030028 FDA UDI
- FDA Product Code
- MTA FDA UDI
- GMDN Term
- Anterior-chamber intraocular lens, phakic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Verisyse by Ophtec B.V. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P030028 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 III | Pending data |
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Manufacturer
- Manufacturer
- Ophtec B.V.
Sources (1)
- FDA UDI 8e04f075-dd49-4505-aebc-d7a5a8e5e7f2 39 fields · synced Jun 1, 2026