FDA.reportPublic FDA data

Melgisorb

Primary DI
05032749040912
Brand
Melgisorb
Company
ADVANCED MEDICAL SOLUTIONS LIMITED
Model
Ag Alginate
Catalog number
255150
Device description
Melgisorb Ag Antimicrobial Alginate Dressing, 15 x 15 cm
Published
2025-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090453000SILVER ALGINATE 11 WOUND DRESSINGAdvanced Medical Solutions Limited2009-02-26FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05032749040912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05032749040912050327490409125032749040912

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
770434090
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
15032749000098ActivHealHydrocolloid Film Backed100086312023-05-05
15032749000104ActivHealHydrocolloid Film Backed100085282023-05-05
15032749000128ActivHealHydrocolloid Film Backed100085302023-05-05
15032749000166ActivHealHydrocolloid Foam Backed10009002 2023-05-05
15032749000173ActivHealHydrocolloid Foam Backed100090032023-05-05
15032749000180ActivHealHydrocolloid Foam Backed100090042023-05-05
15032749000197ActivHealHydrocolloid Foam Backed100090052023-05-05
10612479250380McKesson Moisture Wicking Fabric Ag 16-10144R2022-12-08
10612479250403McKesson Moisture Wicking Fabric Ag 16-1036S2022-12-08
07332551227340MelgisorbAg Alginate2551502022-12-08
07332551227357MelgisorbAg Alginate2551002022-12-08
07332551227364MelgisorbAg Alginate2550502022-12-08
07332551242831MelgisorbAg Alginate2552002022-12-08
07332551992040MelgisorbAg Alginate2556002022-12-08
05032749040851MelgisorbAg Alginate2550502025-04-14
05032749040882MelgisorbAg Alginate2551002025-04-14
05032749040943MelgisorbAg Alginate2552002025-04-14
05032749040974MelgisorbAg Alginate2556002025-04-14
15032749039166Actibride™Debridement Pad90391692024-08-30
25032749041128ActivHealNON ADHESIVE FOAM TRILAM90411242025-02-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26