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Single-use lenses for RESIGHT, MACULA LENS

FDA UDI

Class I (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
Single-use lenses for RESIGHT, MACULA LENS FDA UDI
Generic Name
Ophthalmic surgical microscope lens FDA UDI
Device Name
Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewing system. The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina. FDA UDI
Model / Reference
302721-9107-000 FDA UDI
Description
Single- use lenses for RESIGHT are ophthalmic surgical microscope lenses used in combination with the ZEISS RESIGHT fundus viewing system. The fundus viewing system is an accessory for surgical microscopes which is used for surgery on the posterior segment of the eye. It is used for stereoscopic imaging of the posterior segment and the retina. FDA UDI

Identifiers

Primary DI / UDI-DI
04049539106704 FDA UDI
FDA Product Code
HRM FDA UDI
GMDN Term
Ophthalmic surgical microscope lens FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4700 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 23 Millimeter FDA UDI
Height — 24 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI

Category: Ophthalmic surgical microscope lens

Single-use lenses for RESIGHT, MACULA LENS by Carl Zeiss Meditec AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic surgical microscope lens.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carl Zeiss Meditec AG

Sources (1)

  • FDA UDI 52bb14f7-2bd8-48c3-b216-60a200e6c016 35 fields · synced Jun 8, 2026