SiliGentle Silicone Bordered Foam Dressing - SiliGentle Silicone Bordered Foam Dressing, Large - DYNAREX CORPORATION

Duns Number:008124539

Device Description: SiliGentle Silicone Bordered Foam Dressing, Large Sacral,9"x9"

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More Product Details

Catalog Number

-

Brand Name

SiliGentle Silicone Bordered Foam Dressing

Version/Model Number

3063

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)

-

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

344f30a8-12f2-47aa-ab5e-a325decaf033

Public Version Date

June 29, 2021

Public Version Number

1

DI Record Publish Date

June 21, 2021

Additional Identifiers

Package DI Number

00616784306322

Quantity per Package

5

Contains DI Package

00616784306315

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