Hayden Medical

FDA UDI

Class I (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name: Hayden Medical FDA UDI
Generic Name: Orbital depressor, reusable FDA UDI
Device Name: O'Connor Scleral Depressor / Marker, 5-3/8'', double-ended, 3.0mm wide teardrop-shaped end and 1.5mm Gass marking end, flat handle FDA UDI
Model / Reference: E3-4525 FDA UDI
Description: O'Connor Scleral Depressor / Marker, 5-3/8'', double-ended, 3.0mm wide teardrop-shaped end and 1.5mm Gass marking end, flat handle FDA UDI

Identifiers

Catalog Number: E3-4525 FDA UDI
Primary DI / UDI-DI: 00840319726600 FDA UDI
FDA Product Code: HNX FDA UDI
GMDN Term: Orbital depressor, 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: Orbital depressor, reusable

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

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Schepens Scleral Depressor — SONTEC INSTRUMENTS, INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · 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 d2a49fcd-2bb0-4216-befa-76e50fa93270 35 fields · synced May 30, 2026