Oil Emulsion Dressing - Oil Emulsion Dressing, Non-Adherent, 3"x8" - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Oil Emulsion Dressing, Non-Adherent, 3"x8"

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More Product Details

Catalog Number

-

Brand Name

Oil Emulsion Dressing

Version/Model Number

3068

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

a6dd5549-4bcd-4b03-a7cb-0acb1db03c06

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 01, 2021

Additional Identifiers

Package DI Number

00616784306827

Quantity per Package

24

Contains DI Package

00616784306810

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