OtoLase™ Curved Tip SA-20055400

GUDID 17290109146802

SA-20055400 Box: AC-20055390

LUMENIS LTD.

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

• Primary Device ID: 17290109146802
• NIH Device Record Key: ff32242b-7f93-4a3a-90ab-6b4b76e4dd41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OtoLase™ Curved Tip
• Version Model Number: OtoLase™ Curved Tip
• Catalog Number: SA-20055400
• 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	07290109146805 [Primary]
GS1	17290109146802 [Package]; Contains: 07290109146805; Package: [12 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: 2022-09-12
• Device Publish Date: 2022-09-04

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