CoreTherm

Basic Information

• Brand Name: CoreTherm
• Primary DI: 07350081910075
• Version / Model: Intraprostatic Temperature Probe Short
• Catalog Number: IP807101
• 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: 7b9f0da1-2854-48ee-a772-7588f2c55693

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: Yes
• Sterilization Methods: Hydrogen Peroxide

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
40797	Hyperthermia system temperature probe	A device (a probe) intended to be used exclusively to monitor tissue or body temperature during hyperthermia treatments. Depending on the kind of hyperthermia system it is used with, e.g., ultrasound, radio-frequency (RF) or microwave, this probe is shielded in such a way that its operation is not affected by the energy from the hyperthermia applicator(s) in use during the treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350081910075	GS1

Premarket Submissions

Submission Number	Supplement Number
P010055	009