Pro-Tec

Basic Information

• Brand Name: Pro-Tec
• Primary DI: 00686209052110
• Version / Model: IsoBlend F1
• Catalog Number: 05-0211
• Company Name: Dectro International
• Labeler DUNS: 246237945
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-09
• Public Version: 1
• Public Version Date: 2024-10-17
• Public Version Status: New
• Public Device Record Key: daddcee5-bc30-49cc-9f68-7bfdfe4ba304

Device Description

Hair-removal electrolysis probe, single-use

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCW	Epilator, High Frequency, Needle-Type	General, Plastic Surgery	878.5350	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
Primary	00686209052110	GS1