HD LenZ Pack for ZEISS RESIGHT®

FDA UDI

Class II (US FDA UDI)

by Oculus Surgical Inc

Identity

Trade Name: HD LenZ Pack for ZEISS RESIGHT® FDA UDI
Generic Name: Vitrectomy contact lens, single-use FDA UDI
Device Name: 1 Each 54416 HD LenZ for ZEISS RESIGHT® & 1 Each 40417 Hassan-Tornambe Contact Lens FDA UDI
Model / Reference: 54010 FDA UDI
Description: 1 Each 54416 HD LenZ for ZEISS RESIGHT® & 1 Each 40417 Hassan-Tornambe Contact Lens FDA UDI

Identifiers

Catalog Number: 54010 FDA UDI
Primary DI / UDI-DI: 00852475007103 FDA UDI
FDA Product Code: LRO FDA UDI
GMDN Term: Vitrectomy contact lens, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 13 Millimeter FDA UDI
Outer Diameter — 18 Millimeter FDA UDI

Category: Ophthalmic diagnostic condensing lens Vitrectomy contact lens, single-use

HD LenZ Pack for ZEISS RESIGHT® by Oculus Surgical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vitrectomy contact lens, single-use.

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Disposable 30 Deg. Vitrectomy — OCULAR INSTRUMENTS, INC. · Class II
Disposable Direct Image 1.5x Mag (VMD) — VOLK OPTICAL INC. · Class II
PHAKOS — Phakos · Class II
PHAKOS — Phakos · 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: Oculus Surgical Inc

Sources (1)

FDA UDI e26e5521-73b2-4a54-850b-34433063eaef 37 fields · synced May 30, 2026