Catalog Number

100003

Brand Name

Ankle/Foot 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

eac7bba6-6499-4a4f-b47b-26a8108fe38b

Public Version Date

April 12, 2019

Public Version Number

2

DI Record Publish Date

April 02, 2019

Package DI Number

00850004813171

Quantity per Package

1

Contains DI Package

00850004813027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton