Thermoguide Workstation

GUDID 17340007000833

Clinical Laserthermia Systems AB

MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software MRI system application software

• Primary Device ID: 17340007000833
• NIH Device Record Key: 7e7e2285-8b5f-4bb5-b1f8-b75c225ef754
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermoguide Workstation
• Version Model Number: 1100-N1
• Company DUNS: 774856749
• Company Name: Clinical Laserthermia Systems AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17340007000833 [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