FDA.reportPublic FDA data

UrgoCell Ag/Silver

Primary DI
00190769093457
Brand
UrgoCell Ag/Silver
Company
URGO MEDICAL NORTH AMERICA, LLC
Model
509345
Catalog number
509345
Device description
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.
Published
2019-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10190769093454PackageGS112In Commercial Distribution
00190769093457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019076909345410190769093454
00190769093457001907690934571907690934570190769093457

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store away from light
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
855-888-8273info@us.urgo.com

Regulatory Flags#

DUNS number
052758618
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851383003122Vashe Wound Solution 118 ml container - Flip Cap003122019-12-02
00851383003146Vashe Wound Solution 475 ml (16 fl oz) Flip Top Cap Container00314003142020-02-03
00851383003160Vashe Wound Solution 250 ml (8.5 fl oz) Instillation Cap Container00316003162020-02-07
00851383003177Vashe Wound Solution 475 ml (16 fl oz) Instillation Container00317003172020-04-01
00851383003221Vashe Wound Solution 1 L (34 fl oz) Flip Top Container00322003222020-04-01
00851383003238Vashe Wound Solution 1 L (34 fl oz) Instillation Cap Container00323003232020-04-01
00851383003139Vashe Wound Solution 250 ml (8.5 fl oz) Flip Top Cap00313003132020-02-03
00851383003634Vashe Antimicrobial Wound Gel 118 mL Laminate Tube - Flip Top Cap003602025-11-17
00190769003555Vashe Sterile Sleeve00355003552017-07-17
00190769003548Vashe Wipes Skin Cleansing Solution Kit00354003542018-03-28
00190769004057Vashe Wound Solution OTC00405004052021-12-07
00190769532437URGOK2 5532435532432019-12-26
00190769532468URGOK2 Lite 5532465532462019-12-20
00190769532444URGOK2 5532445532442019-12-20
00190769532451URGOK2 Lite 5532455532452019-12-20
00851383003528Drawtex Hydroconductive Wound Dressing with LevaFiber Edema Wrap00352003522020-02-03
00851383003214Drawtex Hydroconductive Wound Dressing with LevaFiber 18 X 0.3900321003212019-12-02
00851383003009Drawtex Hydroconductive Wound Dressing with LevaFiber 2X2 00300003002019-11-01
00851383003016Drawtex Hydroconductive Wound Dressing with LevaFiber 3X300301003012019-11-01
00851383003023Drawtex Hydroconductive Wound Dressing with LevaFiber 4X400302003022019-11-01

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