Permablate

Basic Information

• Brand Name: Permablate
• Primary DI: 00860004198826
• Version / Model: PEU-K01
• Catalog Number: PEU-K01
• Company Name: GMMI SDN. BHD.
• Labeler DUNS: 865757421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-13
• Public Version: 2
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 7515164c-a426-47ca-ac3c-d7496cdd79d0

Device Description

Permablate Electrolysis Unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPY	Unit, Electrolysis, Battery-Powered, Ophthalmic	Ophthalmic	886.4250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63883	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00860004198833	GS1	Carton	32	In Commercial Distribution
Primary	00860004198826	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]