Hand Piece, external, Packaged, CO2RE Intima AS90244US

GUDID 07290109950501

Hand Piece, external, Packaged, CO2RE Intima

SYNERON MEDICAL LTD

Dermatological carbon dioxide laser system

• Primary Device ID: 07290109950501
• NIH Device Record Key: 275825ab-42e4-4056-8425-df179d66a2a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand Piece, external, Packaged, CO2RE Intima
• Version Model Number: AS90244US
• Catalog Number: AS90244US
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109950501 [Primary]
GS1	17290109950508 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151655
• Premarket Notification: K181523

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-26

On-Brand Devices [Hand Piece, external, Packaged, CO2RE Intima]

• 07290109950747: Hand Piece, external, Packaged, CO2RE Intima
• 07290109950501: Hand Piece, external, Packaged, CO2RE Intima