Catalog Number

-

Brand Name

SOVARCATE

Version/Model Number

DMT-4318

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 19, 2019

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d1c67b58-0c51-446f-99f0-375f7a9c3783

Public Version Date

December 27, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2019

Package DI Number

16970392210749

Quantity per Package

15

Contains DI Package

06970392210742

Package Discontinue Date

December 04, 2019

Package Status

Not in Commercial Distribution

Package Type

inner box