Catalog Number

ES100X

Brand Name

ES100X MiniDop

Version/Model Number

ES100X

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K840542

Product Code

JOP

Product Code Name

Transducer, Ultrasonic

Public Device Record Key

bae095e4-f6d4-467b-9c46-cdcc8f50bcb9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-