CoreTherm SP808601

GUDID 07350081910044

Prostalund AB

Hyperthermia system temperature probe
Primary Device ID07350081910044
NIH Device Record Key56fecc71-3198-4fc3-a1b3-50b5d3ecfce8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoreTherm
Version Model NumberPenis Safety Probe
Catalog NumberSP808601
Company DUNS554703897
Company NameProstalund AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350081910044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-07

On-Brand Devices [CoreTherm]

07350081910082Catheter Short
07350081910075Intraprostatic Temperature Probe Short
07350081910068Microwave Antenna Short
07350081910051Catheter Standard
07350081910044Penis Safety Probe
07350081910037Rectal Temperature Probe
07350081910020Intraprostatic Temperature Probe Standard
07350081910013Microwave Antenna Standard

Trademark Results [CoreTherm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CORETHERM
CORETHERM
79088652 4033358 Dead/Cancelled
ProstaLund Operations AB
2010-05-19
CORETHERM
CORETHERM
78102690 2745160 Live/Registered
PROSTALUND OPERATIONS AB
2002-01-15
CORETHERM
CORETHERM
73403811 not registered Dead/Abandoned
RESPIRATORY CARE INC.
1982-11-24

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