FDA.reportPublic FDA data

ActivHeal

Primary DI
15032749025015
Brand
ActivHeal
Company
ADVANCED MEDICAL SOLUTIONS LIMITED
Model
Ag Postoperative Ionic Silver
Catalog number
9025018
Device description
ACTIVHEAL GLOBAL SURGICAL AG 9X10CM
Published
2023-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K180634000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180634000Surgical Silver Post Operative DressingAdvanced Medical Solutions, Ltd.2018-08-07FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15032749025015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1503274902501515032749025015

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

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
05032749040912MelgisorbAg Alginate2551502025-04-14
05032749040943MelgisorbAg Alginate2552002025-04-14
05032749040974MelgisorbAg Alginate2556002025-04-14
15032749039166Actibride™Debridement Pad90391692024-08-30

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Primary DI, Brand, Company table
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00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
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