Pretika

Basic Information

• Brand Name: Pretika
• Primary DI: 00813859002893
• Version / Model: ST289
• Catalog Number: ST289
• Company Name: PRETIKA CORPORATION
• Labeler DUNS: 848304379
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 1
• Public Version Date: 2020-05-08
• Public Version Status: New
• Public Device Record Key: 25c4a077-af82-4bf0-ad6e-dd4d0035b07a

Device Description

SonicDermabrasion 2.0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• 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: Yes
• 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
ISA	Massager, therapeutic, electric	Physical Medicine	890.5660	1
GET	MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64428	Ultrasonic skin surface treatment unit	An electrically-powered, hand-held device intended to apply ultrasonic vibration to the skin surface, typically the face, for treatment of acne and/or for deep cleansing. It is used in timed sessions where the vibrational energy is intended to open and unclog skin pores. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20813859002897	GS1	Master Carton	3	In Commercial Distribution
Package	10813859002890	GS1	Kit	2	In Commercial Distribution
Primary	00813859002893	GS1

Customer Contacts

• Phone: [phone] ext. 101
• Email: [email protected]