DynaFoam AG Silver Foam Dressing, Bordered - DynaFoam AG Silver Foam Dressing, Bordered, 4" x - DYNAREX CORPORATION

Duns Number:008124539

Device Description: DynaFoam AG Silver Foam Dressing, Bordered, 4" x 4" (10cm x 10cm), High Absorbency, For Wo DynaFoam AG Silver Foam Dressing, Bordered, 4" x 4" (10cm x 10cm), High Absorbency, For Wound Stages 3,4

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More Product Details

Catalog Number

-

Brand Name

DynaFoam AG Silver Foam Dressing, Bordered

Version/Model Number

3049

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

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

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

88db32a3-7d1a-43eb-87d3-056d40c8123d

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

Additional Identifiers

Package DI Number

00616784304922

Quantity per Package

10

Contains DI Package

00616784304915

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2