Permablate PEU-K01

GUDID 00860004198833

Permablate Electrolysis Unit

GMMI SDN. BHD.

Hair-removal electrolysis system needle electrode, single-use
Primary Device ID00860004198833
NIH Device Record Key7515164c-a426-47ca-ac3c-d7496cdd79d0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePermablate
Version Model NumberPEU-K01
Catalog NumberPEU-K01
Company DUNS865757421
Company NameGMMI SDN. BHD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com
Phone+6053131912
Emailnicole.leow@gmmi-med.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004198826 [Primary]
GS100860004198833 [Package]
Contains: 00860004198826
Package: Carton [32 Units]
In Commercial Distribution

FDA Product Code

HPYUnit, Electrolysis, Battery-Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-12-21
Device Publish Date2020-11-13

Devices Manufactured by GMMI SDN. BHD.

00860004198833 - Permablate2020-12-21Permablate Electrolysis Unit
00860004198833 - Permablate2020-12-21 Permablate Electrolysis Unit
10860004198809 - Stylet – Tracheal Tube/ Bougie Catheter2020-12-09

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