Home GUDID 00860004198833 Permablate
Primary DI 00860004198833
Brand Permablate
Company GMMI SDN. BHD.
Model PEU-K01
Catalog number PEU-K01
Device description Permablate Electrolysis Unit
Published 2020-11-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name HPY Unit, Electrolysis, Battery-Powered, Ophthalmic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HPY Unit, Electrolysis, Battery-Powered, Ophthalmic Ophthalmic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860004198833 Package GS1 32 In Commercial Distribution 00860004198826 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860004198833 00860004198833 860004198833 0860004198833 00860004198826 00860004198826 860004198826 0860004198826
GMDN Terms# Term, Definition table Term Definition Hair-removal electrolysis system needle electrode, single-use A sterile device designed as a needle-shaped electrode used together with a hair-removal electrolysis system and used to destroy the dermal papilla (hair root) through application of an electric current from the parent device via the tip of this device that is inserted close to the hair shaft, under the skin, and into the dermal papilla. This is a single-use device.
Regulatory Flags# DUNS number 865757421 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860004198857 SüpeVac – Portable Single Use Hand-Held Suction Device CM200 CM200 2025-05-23 00860004198864 Stylet – Tracheal Tube/ Bougie Catheter CM002 CM002 2025-05-23 10860004198854 SüpeVac – Portable Single Use Hand-Held Suction Device CM200 CM200 2025-05-23 10860004198861 Stylet – Tracheal Tube/ Bougie Catheter CM002 CM002 2025-05-23 00860004198802 Stylet – Tracheal Tube/ Bougie Catheter CM001 CM001 2020-06-08 00860004198826 Permablate PEU-K01 PEU-K01 2020-11-13 10860004198809 Stylet – Tracheal Tube/ Bougie Catheter CM001 CM001 2020-06-08
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860004198826 Permablate GMMI SDN. BHD. HPY 2020-11-13
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