ALLEVYN Gentle Border Lite 10cm x 10cm - ALLEVYN Gentle Border Lite 10cm x 10cmSilicone - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: ALLEVYN Gentle Border Lite 10cm x 10cmSilicone gel adhesive hydrocellular foam dressing

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More Product Details

Catalog Number

66020408, 66800835

Brand Name

ALLEVYN Gentle Border Lite 10cm x 10cm

Version/Model Number

66020408

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

a0c40221-be70-4f73-a9b3-502751668a5e

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

July 04, 2019

Additional Identifiers

Package DI Number

05000223482985

Quantity per Package

10

Contains DI Package

05000223475499

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