Catalog Number

100014

Brand Name

16 Channel Breast SatPad™

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

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

K926416,K926416

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

07a96c87-14b4-4f60-b8cf-9643f12f4009

Public Version Date

April 12, 2019

Public Version Number

2

DI Record Publish Date

April 02, 2019

Package DI Number

00850004813201

Quantity per Package

1

Contains DI Package

00850004813140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton