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Plasma+

FDA UDI

Class II (US FDA UDI)

by Med Pen Concepts LLC

Identity

Trade Name
Plasma+ FDA UDI
Generic Name
Electrosurgical handpiece, reusable FDA UDI
Device Name
Electrosurgical Handpiece FDA UDI
Model / Reference
Plasma+ FDA UDI
Description
Electrosurgical Handpiece FDA UDI

Identifiers

Primary DI / UDI-DI
00860010385616 FDA UDI
510(k) Number
K223440 FDA UDI
FDA Product Code
QVJ FDA UDI
GMDN Term
Electrosurgical handpiece, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrosurgical handpiece, reusable

Plasma+ by Med Pen Concepts LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical handpiece, reusable.

Cleared under the same submission

K223440 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Med Pen Concepts LLC

Sources (1)

  • FDA UDI 00ae9adf-839f-4c2d-b0ba-177f7e42689b 36 fields · synced Jun 7, 2026