Finexel

GUDID 08800086000039

SNJ CO., LTD

General/multiple surgical carbon dioxide laser system

• Primary Device ID: 08800086000039
• NIH Device Record Key: bcab82bd-1f29-4e9c-a295-029a39e3dea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Finexel
• Version Model Number: Finexel
• Company DUNS: 688224067
• Company Name: SNJ CO., 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800086000039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213557

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: 2023-05-11
• Device Publish Date: 2023-05-03

Devices Manufactured by SNJ CO., LTD

• 08800086000077 - Finebeam: 2023-05-18
• 08800086000015 - Finebeam: 2023-05-11
• 08800086000039 - Finexel: 2023-05-11
• 08800086000039 - Finexel: 2023-05-11