Catalog Number

4522-132-64751

Brand Name

MEDRAD® eCoil Imaging System (for Philips Ingenia)

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

K063342,K063342

Product Code

MOS

Product Code Name

Coil, Magnetic Resonance, Specialty

Public Device Record Key

9c3e5e24-fc84-4a49-b08c-610f9d85cd53

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10616258009268

Quantity per Package

5

Contains DI Package

00616258009261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX