FDA.reportPublic FDA data

CoreTherm

Primary DI
07350081910013
Brand
CoreTherm
Company
Prostalund AB
Model
Microwave Antenna Standard
Catalog number
AN806001
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
07350081910013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081910013073500819100137350081910013

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia system applicator, intracorporealA component of a microwave hyperthermia system designed to be placed inside the body to deliver microwave energy to produce a systemic or local heating effect. It is also referred to as an interstitial applicator or probe and is typically a catheter-enclosed conductor of microwave energy that is introduced into the body either manually or endoscopically. It typically includes a thermometry component that monitors the temperature of the device during operation. This is a single-use 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
07350081910020CoreThermIntraprostatic Temperature Probe StandardIP8076012016-03-07
07350081910037CoreThermRectal Temperature ProbeRP8096012016-03-07
07350081910044CoreThermPenis Safety ProbeSP8086012016-03-07
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
07350081910020CoreThermProstalund ABMEQ2016-03-07
07350081910037CoreThermProstalund ABMEQ2016-03-07
07350081910044CoreThermProstalund 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