Binocular Indirect Ophthalmoscope

FDA UDI

Class II (US FDA UDI)

by Neitz Instruments Company, Ltd.

Identity

Trade Name: Binocular Indirect Ophthalmoscope FDA UDI
Generic Name: Indirect binocular ophthalmoscope FDA UDI
Model / Reference: IO-a LED BP-II SET2 FDA UDI

Identifiers

Catalog Number: 108851 FDA UDI
Primary DI / UDI-DI: 04571328642167 FDA UDI
FDA Product Code: HLJ FDA UDI
GMDN Term: Indirect binocular ophthalmoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.1570 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Indirect binocular ophthalmoscope

Binocular Indirect Ophthalmoscope by Neitz Instruments Company, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Neitz Instruments Company, Ltd.

Sources (1)

FDA UDI 30b2166d-0ad6-4778-9806-5e017a8bdb93 34 fields · synced Jun 6, 2026