Slimline™ 200 D/F/L

GUDID 07290109140261

LUMENIS LTD.

General/multiple surgical solid-state laser system

• Primary Device ID: 07290109140261
• NIH Device Record Key: 302d0416-da10-4e1c-9717-75c120cf3697
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slimline™ 200 D/F/L
• Version Model Number: Slimline 200 DFL 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	07290109140261 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140388

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[07290109140261]

Moist Heat or Steam Sterilization

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

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