Ocular Exam Neonatal Speculum

FDA UDI

Class I (US FDA UDI)

by Neotech Products LLC

Identity

Trade Name: Ocular Exam Neonatal Speculum FDA UDI
Generic Name: Eyelid speculum, single-use FDA UDI
Device Name: Disposable Neonatal Speculum FDA UDI
Model / Reference: 10812594012515 FDA UDI
Description: Disposable Neonatal Speculum FDA UDI

Identifiers

Catalog Number: N6500 FDA UDI
Primary DI / UDI-DI: 10812594012515 FDA UDI
FDA Product Code: FXG FDA UDI
GMDN Term: Eyelid speculum, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.1800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

High-level Disinfectant FDA UDI

Category: Eyelid speculum, single-use

Ocular Exam Neonatal Speculum by Neotech Products LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Eyelid speculum, single-use.

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Malosa Medical — Beaver-Visitec International, Inc. · Class I
Sklar — Sklar Corporation · Class I
Barraquer Neonatal Speculum with Finger tips — BLINK MEDICAL LIMITED · Class I
Sklar — Sklar Corporation · Class I
EYE SPECULA — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
Speculum Neo-Natal Angled Temporal — BLINK MEDICAL LIMITED · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Neotech Products LLC

Sources (1)

FDA UDI 5fb490d4-76ad-4d0e-bf51-20ec9bb400ee 34 fields · synced May 30, 2026