ALLEVYN GENTLE 15CM X 15CM CTN 3 - Silicone gel adhesive hydrocellular foam dressing - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Silicone gel adhesive hydrocellular foam dressing

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More Product Details

Catalog Number

66802141, 66802131

Brand Name

ALLEVYN GENTLE 15CM X 15CM CTN 3

Version/Model Number

66802141

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

557615f0-02ca-4147-812e-0eb5f511bcb2

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

05000223495206

Quantity per Package

3

Contains DI Package

05000223494797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton 66802141

"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