Catalog Number

-

Brand Name

EOS

Version/Model Number

EosStethoscope

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2018

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"

Yes

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

HGN

Product Code Name

Stethoscope, Fetal

Public Device Record Key

91436813-6b3a-464a-a046-524b1e26955e

Public Version Date

December 31, 2018

Public Version Number

1

DI Record Publish Date

November 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-