MediMax Tech

FDA UDI

Class II (US FDA UDI)

by Medimax Tech Inc.

Identity

Trade Name: MediMax Tech FDA UDI
Generic Name: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Device Name: SPEC-5 - EvaQMaxPen, Smoke Pencil, Eco, Button, Holster, Non-Stick Blade, 5 meter Hose- Each FDA UDI
Model / Reference: SPEC-5 FDA UDI
Description: SPEC-5 - EvaQMaxPen, Smoke Pencil, Eco, Button, Holster, Non-Stick Blade, 5 meter Hose- Each FDA UDI

Identifiers

Primary DI / UDI-DI: 00817325023504 FDA UDI
510(k) Number: K092732 FDA UDI
K143103 FDA UDI
FDA Product Code: GEI FDA UDI
GMDN Term: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Open-surgery electrosurgical handpiece/electrode, monopolar, reusable Surgical plume evacuation system

MediMax Tech by Medimax Tech Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K092732 also covers:

K143103 also covers:

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: Medimax Tech Inc.

Sources (1)

FDA UDI e048f8b4-e63d-4510-8482-8cc04d299322 35 fields · synced Jun 1, 2026