FDA.reportPublic FDA data

Plaxpot Multi Plasma

Primary DI
08809581025837
Brand
Plaxpot Multi Plasma
Company
GCS Co., Ltd.
Model
GPX-2000
Published
2024-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K220493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220493000Plaxpot Multi PlasmaGcs Co. Limited2023-10-27QVJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809581025837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809581025837088095810258378809581025837

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688549330
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809581021778LEAFGFP-20002024-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08594201094019JETTCOMPEX, spol. s r.o.QVJ2026-04-17
06974223650073Mjolnir Pro.Shenzhen Leaflife Technology Co., Ltd.QVJ2024-09-09
00860010385609PlasmaMDMed Pen Concepts LLCQVJ2024-01-10
00860010385616Plasma+Med Pen Concepts LLCQVJ2024-01-10
08600103856027Plasma+Med Pen Concepts LLCQVJ2023-08-15
08600103856010PlasmaMDMed Pen Concepts LLCQVJ2023-07-20