FDA.reportPublic FDA data

Antibacterial Wound Dressing with Copper with Adhesive Contour #1

Primary DI
07290018406298
Brand
Antibacterial Wound Dressing with Copper with Adhesive Contour #1
Company
MEDCU TECHNOLOGIES LTD
Model
2C-0505-01a
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. External Size 4" x 4". Internal pad size 2" x 2.2"
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
07290018406076PrimaryGS10
07290018406298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018406076072900184060767290018406076
07290018406298072900184062987290018406298

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
532077389
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
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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