Dr. Joel Kaplan

FDA UDI

Class II (US FDA UDI)

by Dr Joel Kaplan Inc

Identity

Trade Name: Dr. Joel Kaplan FDA UDI
Generic Name: Penile vacuum device FDA UDI
Device Name: Metal Hand Pump System - Size Large FDA UDI
Model / Reference: 0302-225-W FDA UDI
Description: Metal Hand Pump System - Size Large FDA UDI

Identifiers

Primary DI / UDI-DI: 00850005747567 FDA UDI
FDA Product Code: LKY FDA UDI
GMDN Term: Penile vacuum device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5020 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

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 2.25 Inch FDA UDI
Length — 9 Inch FDA UDI

Category: Penile vacuum device

Dr. Joel Kaplan by Dr Joel Kaplan Inc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Dr Joel Kaplan Inc

Sources (1)

FDA UDI 9b47d769-43b0-4d63-8166-3c3394326256 35 fields · synced May 31, 2026