AcuPulse™ DUO RG-1000000

GUDID 07290109146027

LUMENIS LTD.

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

• Primary Device ID: 07290109146027
• NIH Device Record Key: 2d7dfe80-ed07-451c-bf01-f8a3f3f30a6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuPulse™ DUO
• Version Model Number: AcuPulse™ DUO
• Catalog Number: RG-1000000
• 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	07290109146027 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-02
• Device Publish Date: 2022-07-25

On-Brand Devices [AcuPulse™ DUO]

• 07290109140292: AcuPulse™ DUO
• 07290109146027: AcuPulse™ DUO
• 07290109147239: AcuPulse™ DUO