Laser Applicator Non-cooled

GUDID 37340007000851

Clinical Laserthermia Systems AB

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 37340007000851
• NIH Device Record Key: 49eb0dda-0ef1-4f07-bdc9-72adb528cad0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Applicator Non-cooled
• Version Model Number: 4017-N2
• Company DUNS: 774856749
• Company Name: Clinical Laserthermia Systems AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	17340007000857 [Primary]
GS1	37340007000851 [Package]; Contains: 17340007000857; Package: [5 Units]; In Commercial Distribution

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: true

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

On-Brand Devices [Laser Applicator Non-cooled]

• 57340007000497: 4012-05
• 57340007000466: 4017-02
• 57340007000459: 4017-01
• 17340007000178: 4012-01
• 37340007000288: 4017-04
• 37340007000271: 4017-03
• 37340007000868: 4017-N4
• 37340007000851: 4017-N2
• 37340007000844: 4012-N5