Identity
- Trade Name
- PHAKOS FDA UDI
- Generic Name
- Vitrectomy contact lens, single-use FDA UDI
- Device Name
- Right gonioprism lens with handle FDA UDI
- Model / Reference
- MV LV 47 FDA UDI
- Description
- Right gonioprism lens with handle FDA UDI
Identifiers
- Catalog Number
- MV LV 47 FDA UDI
- Primary DI / UDI-DI
- B564MVLV470 FDA UDI
- FDA Product Code
- HJK FDA UDI
- GMDN Term
- Vitrectomy contact lens, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1385 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
Ethylene Oxide FDA UDI
Category: Vitrectomy contact lens, single-use
Phakos by Phakos — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vitrectomy contact lens, single-use.
- MAGNIFIER LENS — Katena Products, Inc. · Class II
- Irrigating Contact Lens — ESCALON MEDICAL CORP · Class I
- HD LenZ Pack for ZEISS RESIGHT® — OCULUS SURGICAL INC · Class II
- Disposable 30 Deg. Vitrectomy — OCULAR INSTRUMENTS, INC. · Class II
- Disposable Direct Image 1.5x Mag (VMD) — VOLK OPTICAL INC. · Class II
- BI-CONCAVE LENS — Katena Products, Inc. · Class II
- SUPER VIEW® Pack for ZEISS RESIGHT® — INSIGHT INSTRUMENTS, INC.
- Vitrectomy contact lens, single-use — FCI S A S FCI 20 22 · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phakos
Sources (1)
- FDA UDI a994f3ea-8417-40b3-a9d1-875dfee42bce 34 fields · synced Jun 1, 2026