Pretika ST289

GUDID 20813859002897

SonicDermabrasion 2.0

PRETIKA CORPORATION

Ultrasonic skin surface treatment unit

• Primary Device ID: 20813859002897
• NIH Device Record Key: 25c4a077-af82-4bf0-ad6e-dd4d0035b07a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pretika
• Version Model Number: ST289
• Catalog Number: ST289
• Company DUNS: 848304379
• Company Name: PRETIKA CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(949)488-8818
• Email: thomasnichols@pretika.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813859002893 [Primary]
GS1	10813859002890 [Package]; Contains: 00813859002893; Package: Kit [2 Units]; In Commercial Distribution
GS1	20813859002897 [Package]; Contains: 10813859002890; Package: Master Carton [3 Units]; In Commercial Distribution

FDA Product Code

• ISA: Massager, therapeutic, electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [Pretika]

• 00813859002619: Pretika SonicLift Facial Toning Device: Microcurrent device FDA cleared for at-home-use for a vi
• 10813859002906: Pretika® Advanced Acne Cleansing Brush
• 20813859002897: SonicDermabrasion 2.0
• 20813859002880: SonicLift 2.0
• 20813859002811: SonicDermabrasion® Pro Series
• 10813859002746: Pretika Thermal Control Foot Massager
• 10813859001022: Pretika Rotating Facial Brush
• 10813859001480: Makeup Remover Power Cleanser