FDA.reportPublic FDA data

Targis

Primary DI
M876RB3131A2
Brand
Targis
Company
Urologix LLC
Model
RB3131A
Device description
RTU Plus Reusable Handle, 3 Pack
Published
2014-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M876RB3131A2PrimaryHIBCC0
M876RB3131A0Unit of UseHIBCC0

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
High-level Disinfectant

Regulatory Flags#

DUNS number
785735796
Device count
3
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M87689290Prostiva Hand Piece89292016-09-22
M876PT10340TargisPT10342014-09-26
M876PT10360TargisPT10362014-09-26
M876PT10380TargisPT10382014-09-26
M876RB3131A1TargisRB3131A2014-09-26

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
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