SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III AS8334A

GUDID 07290109950808

SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III

SYNERON MEDICAL LTD

Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system Multi-modality skin contouring system

• Primary Device ID: 07290109950808
• NIH Device Record Key: 0253e8b4-f238-4763-914c-f0324e8230e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
• Version Model Number: AS8334A
• Catalog Number: AS8334A
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109950808 [Primary]
GS1	17290109950805 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	37290109950809 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120510
• Premarket Notification: K122579

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-26

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• 17290109950379 - Internal, CO2RE Intima: 2019-02-07 Internal, CO2RE Intima
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• 07290109950273 - Lens, Gold & Silver: 2019-02-07 Lens, Gold & Silver Assy, CO2RE