Catalog Number

-

Brand Name

DORM DOC

Version/Model Number

MT-403

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

98eb3149-7af4-4cbe-b2d1-f9f3fb1e9a73

Public Version Date

February 28, 2019

Public Version Number

1

DI Record Publish Date

January 28, 2019

Package DI Number

26939663911942

Quantity per Package

580

Contains DI Package

06939663911948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-