CoreTherm

Basic Information

• Brand Name: CoreTherm
• Primary DI: 07350081910013
• Version / Model: Microwave Antenna Standard
• Catalog Number: AN806001
• Company Name: Prostalund AB
• Labeler DUNS: 554703897
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-07
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9bc696a5-7ed3-408b-9f6b-498b21c10cc2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEQ	System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
40792	Microwave hyperthermia system applicator, intracorporeal	A component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device during operation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350081910013	GS1

Premarket Submissions

Submission Number	Supplement Number
P010055	009