Plasma+

Primary DI
08600103856027
Brand
Plasma+
Company
Med Pen Concepts LLC
Model
Plasma+
Catalog number
CS-100002
Device description
Electrosurgical Handpiece
Published
2023-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVJLow Power Electrosurgical Devices For Skin Lesion Destruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVJLow Power Electrosurgical Devices For Skin Lesion DestructionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223440000Plasma Pen (Plasma MD); Plasma Pen (Plasma +)Plasma Concepts2023-03-02QVJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600103856027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600103856027086001038560278600103856027

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, reusableA hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to the generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 274-5684support@plasmaconcepts.com

Regulatory Flags#

DUNS number
119006347
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010385609PlasmaMDPlasmaMD2024-01-10
00860010385616Plasma+Plasma+2024-01-10
00860010385623Professional Plasma Tip Treatment PackProfessional Plasma Tip Treatment Pack2024-01-10
08600103856010PlasmaMDPlasmaMDCS-1000012023-07-20
08600103856034Plasma Concepts Professional Plasma Tip Treatment PackProfessional Tip Treatment PackCS-5000012023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08594201094019JETTCOMPEX, spol. s r.o.QVJ2026-04-17
08809581025837Plaxpot Multi Plasma GCS Co., Ltd.QVJ2024-11-14
06974223650073Mjolnir Pro.Shenzhen Leaflife Technology Co., Ltd.QVJ2024-09-09
00860010385609PlasmaMDMed Pen Concepts LLCQVJ2024-01-10
00860010385616Plasma+Med Pen Concepts LLCQVJ2024-01-10
08600103856010PlasmaMDMed Pen Concepts LLCQVJ2023-07-20