Catalog Number

-

Brand Name

Slight Touch

Version/Model Number

St-501

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

2014cbdb-8624-4c2b-bb6e-81ebdb98ff7a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Package DI Number

10862478000312

Quantity per Package

48

Contains DI Package

00862478000315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-