Model: 10cm×10cm
DI: 16958868743069
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
Hydrocolloid Dressing;10cm×10cm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
041b77ff-3200-49a2-b748-d3001be898b9
Distribution Status:
In Commercial Distribution
DUNS Number:
527587815
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
26958868743066
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
16958868743069
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16958868743069
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
box
Item #3 - Device ID:
46958868743060
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
68
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
26958868743066
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 43186
Name: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Definition:
A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.
FDA Product Codes
NEC
Bandage, Liquid, Skin Protectant