Tissue Temp Probe

GUDID 17340007000109

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system

• Primary Device ID: 17340007000109
• NIH Device Record Key: 2b5bd12b-c5eb-483e-b8d3-8f203ee94cbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue Temp Probe
• Version Model Number: 3203-01
• 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: 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 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	17340007000109 [Primary]
GS1	37340007000103 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	57340007000107 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142216

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-18

On-Brand Devices [Tissue Temp Probe]

• 17340007000109: 3203-01
• 17340007000093: 3103-02
• 17340007000086: 3103-01
• 17340007000079: 3202-01
• 17340007000062: 3102-02
• 17340007000055: 3102-01
• 17340007000048: 3201-01
• 17340007000031: 3101-02
• 17340007000024: 3101-01
• 37340007000721: 3004-02
• 37340007000714: 3004-01
• 37340007000707: 3003-02
• 37340007000691: 3003-01
• 37340007000684: 3002-02
• 37340007000677: 3002-01
• 37340007000660: 3001-02
• 37340007000653: 3001-01