Catalog Number

-

Brand Name

Smilecare

Version/Model Number

UFR101

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200802

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

44470a01-9733-45ae-9fd7-34a41bf5fd00

Public Version Date

April 22, 2022

Public Version Number

2

DI Record Publish Date

January 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-