Catalog Number

-

Brand Name

DxTx Medical 3T eCoil Imaging System Disposables (Prostate - Philips)

Version/Model Number

4522-132-64751

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

834c9ba1-ae8e-4d26-b55e-a012ba5c4b50

Public Version Date

March 05, 2020

Public Version Number

2

DI Record Publish Date

December 11, 2019

Package DI Number

10850011472115

Quantity per Package

5

Contains DI Package

00850011472118

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-