Instructions for use Tranberg Thermoguide Therapy System - US

GUDID 17340007000871

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

• Primary Device ID: 17340007000871
• NIH Device Record Key: 34263b64-8dc3-4459-897e-0fbd3909d257
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instructions for use Tranberg Thermoguide Therapy System - US
• Version Model Number: L-2019-062
• Company DUNS: 774856749
• Company Name: Clinical Laserthermia Systems AB
• 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: false
• Manufacturing Date: false
• 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	17340007000871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214125

FDA Product Code

• ONO: Neurosurgical Laser With Mr Thermography

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: 2022-11-07
• Device Publish Date: 2022-10-28

Devices Manufactured by Clinical Laserthermia Systems AB

• 37340007000950 - MR Introducer: 2024-05-15
• 17340007000611 - Mobile Laser Unit: 2022-11-07
• 37340007000653 - Tissue Temp Probe: 2022-11-07
• 37340007000660 - Tissue Temp Probe: 2022-11-07
• 37340007000677 - Tissue Temp Probe: 2022-11-07
• 37340007000684 - Tissue Temp Probe: 2022-11-07
• 37340007000691 - Tissue Temp Probe: 2022-11-07
• 37340007000707 - Tissue Temp Probe: 2022-11-07