Identity
- Trade Name
- Antibacterial Wound Dressing with Copper #3 FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
- Device Name
- 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" FDA UDI
- Model / Reference
- 2C-1020-01 FDA UDI
- 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" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290018406106 FDA UDI
- 510(k) Number
- K180643 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Wound-nonadherent dressing, absorbent, antimicrobial
Antibacterial Wound Dressing with Copper #3 by Medcu Technologies Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound-nonadherent dressing, absorbent, antimicrobial.
- Suprasorb P Sensitive Ag — L&R USA INC. · U
- Silverlon Antimicrobial Wound Dressing — ARGENTUM MEDICAL, LLC · U
- DeRoyal — DEROYAL INDUSTRIES, INC. · U
- ACTICOAT SURGIC 10X12CM 5PK US — Smith & Nephew Medical, Ltd. · U
- ALLEVYN AG ADHESIVE 7X7" CTN10 — Smith & Nephew Medical, Ltd. · U
- URGOCELL AG/SILVER — LABORATOIRES URGO · U
- Kendall — Cardinalhealth · U
- Exchange Select — Aafes · U
Cleared under the same submission
K180643 also covers:
- Antibacterial Wound Dressing with Copper #1 — MEDCU TECHNOLOGIES LTD
- Antibacterial Wound Dressing with Copper #2 — MEDCU TECHNOLOGIES LTD
- Antibacterial Wound Dressing with Copper #4 — MEDCU TECHNOLOGIES LTD
- Antibacterial Wound Dressing with Copper #5 — MEDCU TECHNOLOGIES LTD
- Antibacterial Wound Dressing with Copper #8 — MEDCU TECHNOLOGIES LTD
- Antibacterial Wound Dressing with Copper with Adhesive Contour #1 — MEDCU TECHNOLOGIES LTD
- Antibacterial Wound Dressing with Copper with Adhesive Contour #2 — MEDCU TECHNOLOGIES LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Medcu Technologies Ltd
Sources (1)
- FDA UDI 6039dc2c-8d97-4510-8590-65c049b69004 35 fields · synced Jun 8, 2026