Identity
- Trade Name
- Artisan/Artiflex FDA UDI
- Generic Name
- Ophthalmic surgical probe, single-use FDA UDI
- Device Name
- Enclavation Needles FDA UDI
- Model / Reference
- OD125A FDA UDI
- Description
- Enclavation Needles FDA UDI
Identifiers
- Catalog Number
- OD125A FDA UDI
- Primary DI / UDI-DI
- 08717819049176 FDA UDI
- 510(k) Number
- K030471 FDA UDI
- FDA Product Code
- MRJ FDA UDI
- GMDN Term
- Ophthalmic surgical probe, single-use 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic surgical probe, single-use
Artisan/Artiflex by Ophtec B.V. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, single-use.
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- Epithelial Spatula — BLINK MEDICAL LIMITED · Class I
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 d771ab9c-6080-4042-a86e-e611b66d6742 37 fields · synced May 30, 2026