Catalog Number

-

Brand Name

ECO SUPERGEL CLEAR

Version/Model Number

ULTRASOUND GEL CLEAR

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K101429

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

bb4708f3-2533-4e72-8f44-ec4b3c6868a2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-