Hayden Medical

FDA UDI

Class I (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name: Hayden Medical FDA UDI
Generic Name: Eyelid speculum, reusable FDA UDI
Device Name: Lieberman Eye Speculum, adjustable mechanism, V-shaped blades are designed to retain the surgical drape under the eyelids, 19mm blades FDA UDI
Model / Reference: E1-1019 FDA UDI
Description: Lieberman Eye Speculum, adjustable mechanism, V-shaped blades are designed to retain the surgical drape under the eyelids, 19mm blades FDA UDI

Identifiers

Catalog Number: E1-1019 FDA UDI
Primary DI / UDI-DI: 00840319753156 FDA UDI
FDA Product Code: HNC FDA UDI
GMDN Term: Eyelid speculum, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4350 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Eyelid speculum, reusable

Hayden Medical by Hayden Medical Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
COOK EYE SPECULUM — SONTEC INSTRUMENTS, 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: Hayden Medical Inc

Sources (1)

FDA UDI f75377a9-36ac-4acf-aa5c-0993251dd6c8 35 fields · synced Jun 8, 2026