Permablate

Primary DI
00860004198826
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HPYUnit, Electrolysis, Battery-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HPYUnit, Electrolysis, Battery-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004198833PackageGS132In Commercial Distribution
00860004198826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004198833008600041988338600041988330860004198833
00860004198826008600041988268600041988260860004198826

GMDN Terms#

Term, Definition table
TermDefinition
Hair-removal electrolysis system needle electrode, single-useA 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.

Contacts#

Phone, Email table
PhoneEmail
+6053131912nicole.leow@gmmi-med.com

Regulatory Flags#

DUNS number
865757421
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004198857SüpeVac – Portable Single Use Hand-Held Suction DeviceCM200CM2002025-05-23
00860004198864Stylet – Tracheal Tube/ Bougie CatheterCM002CM0022025-05-23
10860004198854SüpeVac – Portable Single Use Hand-Held Suction DeviceCM200CM2002025-05-23
10860004198861Stylet – Tracheal Tube/ Bougie CatheterCM002CM0022025-05-23
00860004198802Stylet – Tracheal Tube/ Bougie CatheterCM001CM0012020-06-08
00860004198833PermablatePEU-K01PEU-K012020-11-13
10860004198809Stylet – Tracheal Tube/ Bougie CatheterCM001CM0012020-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860004198833PermablateGMMI SDN. BHD.HPY2020-11-13