CoreTherm SP808601

GUDID 07350081910044

Prostalund AB

Hyperthermia system temperature probe

• Primary Device ID: 07350081910044
• NIH Device Record Key: 56fecc71-3198-4fc3-a1b3-50b5d3ecfce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreTherm
• Version Model Number: Penis Safety Probe
• Catalog Number: SP808601
• Company DUNS: 554703897
• Company Name: Prostalund 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: 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	07350081910044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010055

FDA Product Code

• MEQ: System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

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: 2016-03-07

On-Brand Devices [CoreTherm]

• 07350081910082: Catheter Short
• 07350081910075: Intraprostatic Temperature Probe Short
• 07350081910068: Microwave Antenna Short
• 07350081910051: Catheter Standard
• 07350081910044: Penis Safety Probe
• 07350081910037: Rectal Temperature Probe
• 07350081910020: Intraprostatic Temperature Probe Standard
• 07350081910013: Microwave Antenna Standard