CoreTherm CA804220

GUDID 07350081910051

Prostalund AB

Microwave hyperthermia system applicator, intracorporeal

• Primary Device ID: 07350081910051
• NIH Device Record Key: 33566923-ad20-404c-a906-54b0193c6e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoreTherm
• Version Model Number: Catheter Standard
• Catalog Number: CA804220
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	07350081910051 [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: 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: 2016-03-07

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