Catalog Number

133810F

Brand Name

Exergen Light Touch

Version/Model Number

LTX-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 21, 2021

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K882949

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

55c00d9d-5153-448e-94b7-8b4f50e569b2

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-