CONFORMANT 2 WND VL4X4IN CS48 - Polyethylene wound contact layer - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Polyethylene wound contact layer

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More Product Details

Catalog Number

5955044

Brand Name

CONFORMANT 2 WND VL4X4IN CS48

Version/Model Number

5955044

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

46760c57-6546-440a-aa98-37230ef1b80f

Public Version Date

July 24, 2020

Public Version Number

1

DI Record Publish Date

July 16, 2020

Additional Identifiers

Package DI Number

30040565119305

Quantity per Package

48

Contains DI Package

00040565119304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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