Catalog Number

-

Brand Name

EcoGel 200

Version/Model Number

40JSPC

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

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

K955246,K955246,K955246

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

5d36d3cc-d6c8-4620-8b40-89ed3032a530

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2020

Package DI Number

00628055650683

Quantity per Package

400

Contains DI Package

00628055650676

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case