Hayden Medical

FDA UDI

Class I (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name: Hayden Medical FDA UDI
Generic Name: Ophthalmic surgical probe, reusable FDA UDI
Device Name: Fukasaku Nucleus Chopper Wedge Shaped Flat Interior Cutting Edge with Blunt tip, angled 10mm from bend to tip, round knurled handle, 109mm overall length, stainless steel FDA UDI
Model / Reference: E3-3644 FDA UDI
Description: Fukasaku Nucleus Chopper Wedge Shaped Flat Interior Cutting Edge with Blunt tip, angled 10mm from bend to tip, round knurled handle, 109mm overall length, stainless steel FDA UDI

Identifiers

Catalog Number: E3-3644 FDA UDI
Primary DI / UDI-DI: 00840319726440 FDA UDI
FDA Product Code: HND FDA UDI
GMDN Term: Ophthalmic surgical probe, 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: Ophthalmic surgical probe, reusable

Hayden Medical by Hayden Medical Inc — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Hayden Medical Inc

Sources (1)

FDA UDI 4d2bd6a8-68ff-43b3-a8e3-3c6d35bdb5b9 35 fields · synced May 31, 2026