Hand Piece Internal, Packaged, CO2RE Intima AS89731

GUDID 07290109950730

Hand Piece Internal, Packaged, CO2RE Intima

SYNERON MEDICAL LTD

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• Primary Device ID: 07290109950730
• NIH Device Record Key: 3fb83a30-4d5f-465b-899f-84c3fbd3876a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand Piece Internal, Packaged, CO2RE Intima
• Version Model Number: AS89731
• Catalog Number: AS89731
• 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	07290109950730 [Primary]
GS1	17290109950737 [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

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• 17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima: 2020-02-10 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
• 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