FDA.reportPublic FDA data

URGOTUL

Primary DI
03546890043132
Brand
URGOTUL
Company
LABORATOIRES URGO
Model
603281
Device description
A non-occlusive flexible and conformable dressing comprising of a polyester mesh impregnated with hydrocolloid particle dispersed in a petroleum jelly matrix.
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03546890043132PackageGS110In Commercial Distribution
03546890035915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03546890043132035468900431323546890043132
03546890035915035468900359153546890035915

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. 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
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
397310355
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
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
03546890046379URGOCLEAN AG PAD6040382026-04-14
03546890046461URGOCLEAN AG PAD6040602026-04-14
03546890046782URGOCLEAN AG PAD6041242026-04-14
03546890044290URGOTUL ABSORB BORDER6035532024-11-19
03546890043286URGOTUL6042302025-11-03
03546890047840URGOTUL6043662025-11-03
03546890047932URGOTUL6042982025-11-03
03546890048083URGOTUL6043722025-11-03
03546890048205URGOTUL6043622025-11-03
03546890043255URGOTUL ABSORB6036392024-11-19
03546890043507URGOTUL ABSORB BORDER6035622024-11-19
03546890044016URGOTUL ABSORB BORDER6035172024-11-19
03546890044443URGOTUL ABSORB BORDER6035752024-11-19
03546890044955URGOTUL ABSORB6036342024-11-19
03546890045174URGOTUL ABSORB6036502024-11-19
03546890045297URGOTUL ABSORB6036622024-11-19
03546890045044URGOTUL ABSORB6036392024-11-19
03546890044405URGOTUL ABSORB BORDER6035622024-11-19
03546890044009URGOTUL ABSORB BORDER6035172024-11-19
03546890044177URGOTUL ABSORB BORDER6035532024-11-19

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Primary DI, Brand, Company table
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04260223630347curea P2curea medical GmbHNAC2026-09-27
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