DURAMAX S Silicone super absorbent dressing - Super Absorbent Dressing 6 x 8in - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Super Absorbent Dressing 6 x 8in

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More Product Details

Catalog Number

66023132

Brand Name

DURAMAX S Silicone super absorbent dressing

Version/Model Number

66023132

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Device Record Status

Public Device Record Key

3d85ee0c-69b9-4c4c-b2cc-7d2be587298e

Public Version Date

July 07, 2022

Public Version Number

1

DI Record Publish Date

June 29, 2022

Additional Identifiers

Package DI Number

05000223500801

Quantity per Package

10

Contains DI Package

05000223500795

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SMITH & NEPHEW MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 126
U Unclassified 1