FDA.reportPublic FDA data

URGOCLEAN AG PAD

Primary DI
03546890046379
Brand
URGOCLEAN AG PAD
Company
LABORATOIRES URGO
Model
604038
Device description
Absorbent dressing consisting of a pad of polyacrylate polyabsorbent fibres coated with TLC Ag matrix Technology composed of liquid paraffin, sodium carboxymethylcellulose (CMC) and silver sulfate and polymers.
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
03546890042739PackageGS110In Commercial Distribution
03546890046379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03546890042739035468900427393546890042739
03546890046379035468900463793546890046379

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight, keep dry
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

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
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03546890044450URGOTUL ABSORB BORDER6035752024-11-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00050428034743CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428142349CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
00050428341728CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-10-10
10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072266Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072273Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072280Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072457SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072464SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072471SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
06977727072488SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
10192253072723CurityCardinal Health 200, LLCFRO2026-10-08
10192253072730CurityCardinal Health 200, LLCFRO2026-10-08
10192253072747CurityCardinal Health 200, LLCFRO2026-10-08
10192253072754CurityCardinal Health 200, LLCFRO2026-10-08
10192253072761CurityCardinal Health 200, LLCFRO2026-10-08
10192253072778CurityCardinal Health 200, LLCFRO2026-10-08
10192253072785CurityCardinal Health 200, LLCFRO2026-10-08
10192253072792CurityCardinal Health 200, LLCFRO2026-10-08
10192253072808CurityCardinal Health 200, LLCFRO2026-10-08
10192253072815CurityCardinal Health 200, LLCFRO2026-10-08
10192253072822CurityCardinal Health 200, LLCFRO2026-10-08
00860014518331PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07
00860014518348PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07