EndyMed PRO 85W System Face 110V ND_PRD00006_F_F

GUDID 07290016814170

The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mil

ENDYMED MEDICAL LTD

Multi-modality skin contouring system

• Primary Device ID: 07290016814170
• NIH Device Record Key: bdf542f3-a6d9-457d-b0c9-02d6c12dff59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndyMed PRO 85W System Face 110V
• Version Model Number: PRO 85W System Face 110V
• Catalog Number: ND_PRD00006_F_F
• Company DUNS: 531958689
• Company Name: ENDYMED MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-363-9633
• Email: service@endymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016814170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083461

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-03-21
• Device Publish Date: 2019-03-03

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