FDA.reportPublic FDA data

Antibacterial Wound Dressing with Copper #1

Primary DI
07290018406083
Brand
Antibacterial Wound Dressing with Copper #1
Company
MEDCU TECHNOLOGIES LTD
Model
2C-0506-01
Device description
"Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg & foot ulcers, pressure ulcers, first & second degree burns, surgical wounds; venous and arterial ulcers. Size 2"" x 2.4"""
Published
2022-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180643000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180643000MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies , Ltd.2018-11-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018406083PrimaryGS10
07290018406304Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018406083072900184060837290018406083
07290018406304072900184063047290018406304

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+97297429242info@medcu.com

Regulatory Flags#

DUNS number
532077389
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018406472Antibacterial Wound Dressing with Copper #83C-0218-012025-07-08
07290018406489Antibacterial Wound Dressing with Copper #83C-0218-012025-07-08
07290018406069Antibacterial Wound Dressing with Copper #22C-1012-012022-10-01
07290018406076Antibacterial Wound Dressing with Copper with Adhesive Contour #12C-0505-01a2022-10-01
07290018406090Antibacterial Wound Dressing with Copper with Adhesive Contour #22C-1025-01a2022-10-01
07290018406106Antibacterial Wound Dressing with Copper #32C-1020-012022-10-01
07290018406113Antibacterial Wound Dressing with Copper #42C-2020-012022-10-01
07290018406120Antibacterial Wound Dressing with Copper #53C-1012-012022-10-01
07290018406281Antibacterial Wound Dressing with Copper #22C-1012-012022-10-01
07290018406298Antibacterial Wound Dressing with Copper with Adhesive Contour #12C-0505-01a2022-10-01
07290018406304Antibacterial Wound Dressing with Copper #12C-0506-012022-10-01
07290018406311Antibacterial Wound Dressing with Copper with Adhesive Contour #22C-1025-01a2022-10-01
07290018406328Antibacterial Wound Dressing with Copper #32C-1020-012022-10-01
07290018406335Antibacterial Wound Dressing with Copper #42C-2020-012022-10-01
07290018406342Antibacterial Wound Dressing with Copper #53C-1012-012022-10-01

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Primary DI, Brand, Company table
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10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
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
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04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
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00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08