CARDINAL HEALTH ESSENTIALS - Silver Amorphous Hydrogel; Silver; 1.575 oz Tube - RGH ENTERPRISES

Duns Number:049735438

Device Description: Silver Amorphous Hydrogel; Silver; 1.575 oz Tube

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More Product Details

Catalog Number

ZSHG15

Brand Name

CARDINAL HEALTH ESSENTIALS

Version/Model Number

ZSHG15

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"

Yes

For Single-Use

Yes

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

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, wound, drug

Device Record Status

Public Device Record Key

ee5e3f41-6d8b-4363-aa42-80380e11610f

Public Version Date

December 09, 2021

Public Version Number

2

DI Record Publish Date

April 23, 2019

Additional Identifiers

Package DI Number

00885380115984

Quantity per Package

1

Contains DI Package

10885380115981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"RGH ENTERPRISES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 1