EcoGel 200 - High-Viscosity Blue 5L Cube - Eco-Med Pharmaceutical Inc

Duns Number:249183435

Device Description: High-Viscosity Blue 5L Cube

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More Product Details

Catalog Number

-

Brand Name

EcoGel 200

Version/Model Number

40JS-HV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K955246,K955246

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

58e4e57c-f085-4a36-940b-9aee107c882b

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 15, 2020

Additional Identifiers

Package DI Number

00628055650713

Quantity per Package

4

Contains DI Package

00628055650997

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ECO-MED PHARMACEUTICAL INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 34