Antibacterial Wound Dressing with Copper with Adhesive Contour #2

GUDID 07290018406311

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 10". Internal pad size 2" x 8"

MEDCU TECHNOLOGIES LTD

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID07290018406311
NIH Device Record Key0ea286b1-1c20-4c82-bea9-377090506e4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAntibacterial Wound Dressing with Copper with Adhesive Contour #2
Version Model Number2C-1025-01a
Company DUNS532077389
Company NameMEDCU TECHNOLOGIES LTD
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone+97297429242
Emailinfo@medcu.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290018406090 [Primary]
GS107290018406311 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-10
Device Publish Date2022-10-01

Devices Manufactured by MEDCU TECHNOLOGIES LTD

07290018406281 - Antibacterial Wound Dressing with Copper #22022-10-10 Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg &
07290018406298 - Antibacterial Wound Dressing with Copper with Adhesive Contour #12022-10-10 Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg &
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07290018406311 - Antibacterial Wound Dressing with Copper with Adhesive Contour #22022-10-10Copper 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 10". Internal pad size 2" x 8"
07290018406311 - Antibacterial Wound Dressing with Copper with Adhesive Contour #22022-10-10 Copper impregnated antibactertial wound dressings designed to address a wide variety of wounds including: diabetic wounds, leg &
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