Catalog Number

SP808601

Brand Name

CoreTherm

Version/Model Number

Penis Safety Probe

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P010055

Product Code

MEQ

Product Code Name

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

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

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-