Catalog Number

-

Brand Name

SourceMark

Version/Model Number

SMC400-P-M

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

3fb472c4-e13b-46c3-ac63-a1789dbdf30d

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 04, 2020

Package DI Number

10813799006804

Quantity per Package

10

Contains DI Package

00813799006791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box