Focal 44 Sublative iD, (20 Pulse,Yellow) AS79364

GUDID 07290109951201

Focal 44 Sublative iD, (20 Pulse,Yellow)

SYNERON MEDICAL LTD

Multi-modality skin surface treatment system

• Primary Device ID: 07290109951201
• NIH Device Record Key: 63e890d3-1997-4347-a703-5c768356060c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focal 44 Sublative iD, (20 Pulse,Yellow)
• Version Model Number: AS79364
• Catalog Number: AS79364
• Company DUNS: 532685716
• Company Name: SYNERON 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109951201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090025

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

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