Slimline EZ 550 Fiber

GUDID 17290109140183

LUMENIS LTD.

General/multiple surgical solid-state laser system

• Primary Device ID: 17290109140183
• NIH Device Record Key: fdf30ab3-a0c6-4166-92cd-9bd24a3159ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slimline EZ 550 Fiber
• Version Model Number: Slimline EZ 550 Fiber
• Company DUNS: 600166524
• Company Name: LUMENIS 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

Customer Support Contacts

• Phone: 408-764-3000
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109140186 [Primary]
GS1	17290109140183 [Package]; Contains: 07290109140186; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140388

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

On-Brand Devices [Slimline EZ 550 Fiber]

• 07290109142050: SlimLine EZ 550 Fiber
• 17290109140183: Slimline EZ 550 Fiber