UltraPulse® DUO

GUDID 07290109140322

UltraPulse DUO

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system

• Primary Device ID: 07290109140322
• NIH Device Record Key: 94037194-e04c-480a-9cd2-0b3e3947146e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraPulse® DUO
• Version Model Number: UltraPulse DUO
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	07290109140322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151331

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2016-08-22

On-Brand Devices [UltraPulse® DUO]

• 07290109140322: UltraPulse DUO
• 07290109146133: UltraPulse DUO