Catalog Number

-

Brand Name

ThermoWorks Wand

Version/Model Number

THD2FE

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

K121428,K121428

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

efdb05ce-ec50-4ade-8bd8-a614af5f2cfd

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

April 07, 2020

Package DI Number

10860003705305

Quantity per Package

46

Contains DI Package

00860003705308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Pack