ACTICOAT 7 6" X 6" - 7 day silver-coated antimicrobial barrier dressing - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: 7 day silver-coated antimicrobial barrier dressing

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More Product Details

Catalog Number

20241

Brand Name

ACTICOAT 7 6" X 6"

Version/Model Number

20241

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K001519,K001519,K001519

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

c699d5ab-f1ff-42f2-9f39-8f598c4609c3

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2020

Additional Identifiers

Package DI Number

00040565121451

Quantity per Package

5

Contains DI Package

05000223449940

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