JETT

Primary DI
08594201094019
Brand
JETT
Company
COMPEX, spol. s r.o.
Model
JETT PLASMA Medical II
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K213247000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213247000JETT PLASMA Medical IICompex, Spol, S.R.O.2023-03-14QVJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08594201094019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08594201094019085942010940198594201094019

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system, line-poweredAn assembly of line-powered devices designed to regulate an electrical current used to heat the electrode tip or wire loop of a cutting instrument intended to burn or sear body tissues during surgery. It is typically used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions (e.g., removal of warts, removal of gastrointestinal polyps via an appropriate endoscope), or to occlude fallopian tubes during sterilization procedures. It typically consists of a generator, a handpiece, and electrodes. Unlike electrosurgical diathermy, electrocautery does not involve electrical current passing through the patient.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Liquid Chemical"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
495080822
Device count
1
Serial number
true
Manufacturing date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08594201094293JETTJETT Medical II2026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08600103856027Plasma+Med Pen Concepts LLCQVJ2023-08-15
08600103856010PlasmaMDMed Pen Concepts LLCQVJ2023-07-20