Macan

FDA UDI

Class II (US FDA UDI)

by Macan Manufacturing

Identity

Trade Name: Macan FDA UDI
Generic Name: Electrosurgical system FDA UDI
Device Name: MC-4A (individual Unit) FDA UDI
Model / Reference: MC-4A FDA UDI
Description: MC-4A (individual Unit) FDA UDI

Identifiers

Primary DI / UDI-DI: 00851683006106 FDA UDI
510(k) Number: K050735 FDA UDI
FDA Product Code: EKZ FDA UDI
GMDN Term: Electrosurgical system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4920 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical system

Macan by Macan Manufacturing — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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INTRAcel RF Microneedle System — Jeisys Medical Incorporated · Class II

Cleared under the same submission

K050735 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: Macan Manufacturing

Sources (1)

FDA UDI 2faf10d1-c630-4b41-be3a-84bafc65eaee 35 fields · synced May 30, 2026