FDA.reportPublic FDA data

UrgoTul Ag/Silver Contact Layer 6 X 8

Primary DI
10190769093423
Brand
UrgoTul Ag/Silver Contact Layer 6 X 8
Company
URGO MEDICAL NORTH AMERICA, LLC
Model
509342
Catalog number
509342
Device description
A non-adhesive, non-occlusive, antimicrobial wound contact dressing, composed of a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petrolatum and silver.
Published
2019-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10190769093423PackageGS114In Commercial Distribution
00190769093426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019076909342310190769093423
00190769093426001907690934261907690934260190769093426

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA sterile 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 trauma to the wound and/or causing pain upon removal, 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 Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
052758618
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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