UrgoCell Ag/ Silver - A non-adhesive, non-occlusive, antimicrobial - URGO MEDICAL NORTH AMERICA, LLC

Duns Number:052758618

Device Description: A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester A non-adhesive, non-occlusive, antimicrobial absorbent dressing composed of 1) a polyester mesh impregnated with a matrix comprising of hydrocolloid particle (carboxymethylcellulose), cohesiopolymers, petrolatum and silver sulfate, 2) a non-sensitizing, super absorbent polyurethane foam pad, 3) a protective, semi-permeable polyurethane foam backing.

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More Product Details

Catalog Number

509346

Brand Name

UrgoCell Ag/ Silver

Version/Model Number

509346

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

25e9fae1-c403-4bba-863f-19ea1dcb970f

Public Version Date

September 11, 2020

Public Version Number

5

DI Record Publish Date

March 01, 2019

Additional Identifiers

Package DI Number

10190769093461

Quantity per Package

4

Contains DI Package

00190769093464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"URGO MEDICAL NORTH AMERICA, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 12