AccessGUDID - DEVICE: CoreTherm (07350081910044)

GUDID

Device Identifier (DI) Information

Brand Name: CoreTherm
Version or Model: Penis Safety Probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP808601
Company Name: Prostalund AB

Primary DI Number: 07350081910044
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554703897 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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Product Code	Product Code Name
MEQ	System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010055	009

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56fecc71-3198-4fc3-a1b3-50b5d3ecfce8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 07, 2016