URGOTUL ABSORB BORDER - An adhesive lipido-colloid foam dressing with - LABORATOIRES URGO

Duns Number:397310355

Device Description: An adhesive lipido-colloid foam dressing with soft-adherent TLC and silicone border.Compos An adhesive lipido-colloid foam dressing with soft-adherent TLC and silicone border.Composed of :- a soft-adherent TLC layer combined with an absorbent polyurethane foam pad and a superabsorbent layer- a vapour permeable waterproof outer film with silicone adhesive on the edges

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More Product Details

Catalog Number

-

Brand Name

URGOTUL ABSORB BORDER

Version/Model Number

550764

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"

Yes

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

de6f422b-c064-47fc-ba5c-7bf8d8ed1372

Public Version Date

October 06, 2021

Public Version Number

2

DI Record Publish Date

April 26, 2021

Additional Identifiers

Package DI Number

03546890028511

Quantity per Package

10

Contains DI Package

03546890035120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"LABORATOIRES URGO" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
U Unclassified 5