FiberLase™ Endoscope Protection Sheath SA-1103020

GUDID 07290109146614

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

• Primary Device ID: 07290109146614
• NIH Device Record Key: 3a1135d7-dc5e-44b0-90eb-185b4604a8a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberLase™ Endoscope Protection Sheath
• Version Model Number: FiberLase™ Endoscope Protection Sheath
• Catalog Number: SA-1103020
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109146614 [Primary]
GS1	17290109146611 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-04
• Device Publish Date: 2022-07-27

On-Brand Devices [FiberLase™ Endoscope Protection Sheath]

• 17290109142033: FiberLase™ Endoscope Protection Sheath
• 07290109146614: FiberLase™ Endoscope Protection Sheath