Opsite Post-Op Visible 35x10cm Ctn 20 - Waterproof, bacteria proof dressing with - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Waterproof, bacteria proof dressing with absorbent see through pad

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More Product Details

Catalog Number

66800141

Brand Name

Opsite Post-Op Visible 35x10cm Ctn 20

Version/Model Number

66800141

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

4c6e3466-ae42-4890-b930-43e7756e2fee

Public Version Date

July 08, 2020

Public Version Number

2

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

05000223468699

Quantity per Package

20

Contains DI Package

05000223468637

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