Catalog Number

4522-132-70681

Brand Name

MEDRAD® 1.5T eCoil Imaging System (for Philips)

Version/Model Number

4522-132-70681

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

K901888,K901888

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

2901c8fb-2e5b-45cc-80a4-6c14a4ec3338

Public Version Date

March 05, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10616258009213

Quantity per Package

5

Contains DI Package

00616258009216

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX