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OI-28/GD MaxLight® 28D Binocular Indirect Lens (Gold)

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 9288

by Ocular Instruments Inc.

Identity

Trade Name
OI-28/GD MaxLight® 28D Binocular Indirect Lens (Gold) EUDAMED
MaxLight® 28D Binocular Indirect Lens (Gold) FDA UDI
Generic Name
Ophthalmic diagnostic condensing lens FDA UDI
Device Name
Indirect Lenses EUDAMED
Model / Reference
9288 EUDAMED
OI-28/GD FDA UDI

Identifiers

Primary DI / UDI-DI
00630238092883 EUDAMEDFDA UDI
Basic UDI-DI
06302381262739 EUDAMED
Direct Marketing DI
00630238093040 EUDAMED
FDA Product Code
HJL FDA UDI
EMDN Code
Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
GMDN Term
Ophthalmic diagnostic condensing lens FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
886.1380 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

The OI-28/GD MaxLight 28D Binocular Indirect Lens (Gold) device, used in ophthalmology for cataract surgery, provides a clear and magnified view of the eye. Developed by Ocular Instruments Inc., this product is designed to enhance surgeon confidence during procedures.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ocular Instruments Inc.
EUDAMED SRN
US-MF-000007216
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 114144d5-d445-4518-9a9b-2658f2266520 61 fields · synced Aug 1, 2026
  • FDA UDI 3a6b4d97-1319-450d-bb7a-e0d881b5aa3f 32 fields · synced May 30, 2026