Identity
- Trade Name
- Artisan FDA UDI
- Generic Name
- Anterior-chamber intraocular lens, phakic FDA UDI
- Device Name
- Artisan Myopia 5/8.5mm -18.5D FDA UDI
- Model / Reference
- 206US1W FDA UDI
- Description
- Artisan Myopia 5/8.5mm -18.5D FDA UDI
Identifiers
- Catalog Number
- 206US1W37N FDA UDI
- Primary DI / UDI-DI
- 08717819060607 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
- 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
Category: Anterior-chamber intraocular lens, phakic
Artisan by Ophtec B.V. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anterior-chamber intraocular lens, phakic.
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
- Artisan — Ophtec B.V. · Class III
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 5f486f71-48a9-4b60-a631-6a8df324f6fd 38 fields · synced May 30, 2026