Catalog Number

ES101EX-2

Brand Name

ES101EX

Version/Model Number

ES101EX-2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 03, 2021

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K031504

Product Code

KNG

Product Code Name

Monitor, Ultrasonic, Fetal

Public Device Record Key

e3beb1be-3682-40a4-ba62-3caae10c9276

Public Version Date

February 04, 2021

Public Version Number

4

DI Record Publish Date

February 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-