Catalog Number

-

Brand Name

Good Sense

Version/Model Number

69-358

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K041516,K041516,K041516

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a662ca93-071a-4f35-aec1-2761e64a18d5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10846036007678

Quantity per Package

36

Contains DI Package

30846036007672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON