Powered Laser Surgical Instrument-Trixel CO2 Laser

GUDID 06970285179026

Beijing Syntech Laser Co., Ltd.

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

• Primary Device ID: 06970285179026
• NIH Device Record Key: 5524dd6e-868f-4224-97da-352311af3e71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powered Laser Surgical Instrument-Trixel CO2 Laser
• Version Model Number: CFL-10
• Company DUNS: 528741132
• Company Name: Beijing Syntech Laser 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: true
• 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	06970285179026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110434

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: 2017-06-29

Devices Manufactured by Beijing Syntech Laser Co., Ltd.

• 06970285174281 - Powered Laser Surgical Instrument-Diode Laser: 2018-08-13
• 06970285174168 - Powered Laser Surgical Instrument-Diode Laser Mode: 2018-07-06
• 06970285176018 - Powered Laser Surgical Instrument－APOLLO V+ Medica: 2018-07-06
• 06970285176025 - Powered Laser Surgical Instrument－APOLLO IV+ Medic: 2018-07-06
• 06970285176049 - Powered Laser Surgical Instrument－Nice Station Lig: 2018-07-06
• 06970285176148 - Powered Laser Surgical Instrument－APOLLO IV+ Medic: 2018-07-06
• 06970285179026 - Powered Laser Surgical Instrument-Trixel CO2 Laser: 2018-07-06
• 06970285179026 - Powered Laser Surgical Instrument-Trixel CO2 Laser: 2018-07-06
• 06970285179057 - Powered Laser Surgical Instrument-Trixel II CO2 La: 2018-07-06