FDA.reportPublic FDA data

Antibacterial Wound Dressing with Copper #3

Primary DI
07290018406106
Brand
Antibacterial Wound Dressing with Copper #3
Company
MEDCU TECHNOLOGIES LTD
Model
2C-1020-01
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 4"" x 8"""
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
07290018406106PrimaryGS10
07290018406328Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018406106072900184061067290018406106
07290018406328072900184063287290018406328

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
07290018406083Antibacterial Wound Dressing with Copper #12C-0506-012022-10-01
07290018406090Antibacterial Wound Dressing with Copper with Adhesive Contour #22C-1025-01a2022-10-01
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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