Catalog Number

-

Brand Name

Targis

Version/Model Number

PT1034

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MEQ

Product Code Name

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

Public Device Record Key

b9d843d1-690f-45ae-9a80-4dd5e0dcac1a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 26, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-