SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape I AS87512

GUDID 17290109952705

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

SYNERON MEDICAL LTD

Multi-modality skin contouring system

• Primary Device ID: 17290109952705
• NIH Device Record Key: 3d80a0ff-21b3-487d-a1bd-be989220754b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape I
• Version Model Number: AS87512
• Catalog Number: AS87512
• 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	07290109952701 [Primary]
GS1	17290109952705 [Package]; Contains: 07290109952701; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120510

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: 2017-06-01

On-Brand Devices [SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape I]

• 17290109952705: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
• 07290109950426: SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III