Model: Non-adhesive 10cm×10cm
DI: 16958868753020
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Copper Foam Dressing
Non-adhesive:10cm×10cm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6ef0c8f2-3f00-42f9-bc88-133d60c67e61
Distribution Status:
In Commercial Distribution
DUNS Number:
527587815
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
box
Item #1 - Device ID:
26958868753027
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
16958868753020
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16958868753020
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
box
Item #3 - Device ID:
36958868753024
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
48
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
26958868753027
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 48124
Name: Exudate-absorbent dressing, non-gel, antimicrobial
Definition:
A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.
FDA Product Codes
FRO
Dressing, Wound, Drug
Premarket Submissions
Submission Number:
K231088
Supplement Number:
000