FDA.reportPublic FDA data

CoreTherm

Primary DI
07350081910044
Brand
CoreTherm
Company
Prostalund AB
Model
Penis Safety Probe
Catalog number
SP808601
Published
2016-03-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEQSystem, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),ThermotherapyUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010055009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010055009PROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPHProstalund AB2002-12-23MEQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350081910044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081910044073500819100447350081910044

GMDN Terms#

Term, Definition table
TermDefinition
Hyperthermia system temperature probeA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554703897
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350081910013CoreThermMicrowave Antenna StandardAN8060012016-03-07
07350081910020CoreThermIntraprostatic Temperature Probe StandardIP8076012016-03-07
07350081910037CoreThermRectal Temperature ProbeRP8096012016-03-07
07350081910051CoreThermCatheter StandardCA8042202016-03-07
07350081910068CoreThermMicrowave Antenna ShortAN8061012016-03-07
07350081910075CoreThermIntraprostatic Temperature Probe ShortIP8071012016-03-07
07350081910082CoreThermCatheter ShortCA8041202016-03-07
07350081910099CoreBlocSK820000SK8200002018-06-05
27350081910093CoreBlocSK820000SK8200002018-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350081910013CoreThermProstalund ABMEQ2016-03-07
07350081910020CoreThermProstalund ABMEQ2016-03-07
07350081910037CoreThermProstalund ABMEQ2016-03-07
07350081910051CoreThermProstalund ABMEQ2016-03-07
07350081910068CoreThermProstalund ABMEQ2016-03-07
07350081910075CoreThermProstalund ABMEQ2016-03-07
07350081910082CoreThermProstalund ABMEQ2016-03-07
M876PT10340TargisUrologix LLCMEQ2014-09-26
M876PT10360TargisUrologix LLCMEQ2014-09-26
M876PT10380TargisUrologix LLCMEQ2014-09-26
M876RB3131A1TargisUrologix LLCMEQ2014-09-26
M876RB3131A2TargisUrologix LLCMEQ2014-09-26