Hayden Medical

FDA UDI

Class I (US FDA UDI)

by Hayden Medical Inc

Identity

Trade Name: Hayden Medical FDA UDI
Generic Name: Corneal shield applicator FDA UDI
Device Name: Large Synthetic Latex Free Rubber Suction Cups, autoclavable, one dozen FDA UDI
Model / Reference: OP23-012 FDA UDI
Description: Large Synthetic Latex Free Rubber Suction Cups, autoclavable, one dozen FDA UDI

Identifiers

Catalog Number: OP23-012 FDA UDI
Primary DI / UDI-DI: 00840319716632 FDA UDI
FDA Product Code: KYE FDA UDI
GMDN Term: Corneal shield applicator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.5420 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: Corneal shield applicator

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

Similar devices

Also classified as Corneal shield applicator.

Laser kit — Oculo-Plastik Inc · Class I
Silicone Suction Cup (10pk) — Gulden Ophthalmics · Class I
Latex-free Rubber Suction Cups (100 units) — Oculo-Plastik Inc · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Suction Cups (12 units) — Oculo-Plastik 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 23d71a1f-a14c-4365-9741-00c34c0830b2 35 fields · synced May 30, 2026