FDA.reportPublic FDA data

URGOTUL

Primary DI
03546890048083
Brand
URGOTUL
Company
LABORATOIRES URGO
Model
604372
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
2025-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
03546890048397PackageGS15In Commercial Distribution
03546890048083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03546890048397035468900483973546890048397
03546890048083035468900480833546890048083

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

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
397310355
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

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
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
03546890044450URGOTUL ABSORB BORDER6035752024-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937935316927Sacral Silicone Superabsorbent DressingShanghai Iso Medical Products Co., Ltd.NAC2026-08-03
06979191881955OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881962OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881979OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191882280NanacareWAL-MART STORES, INC.NAC2026-07-31
06974692681561GUANGYIJiangsu Guangyi Medical Dressing Co.,LTD.NAC2026-07-22
01714196634404HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196635500HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196637702HydraLock SA with BorderSion Brands LLCNAC2026-07-16
10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
00197344111513CURADMEDLINE INDUSTRIES, INC.NAC2026-07-03
00197998001727Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295812Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22