Model: 11cm×11cm
DI: 16958868752023
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
Polyver Silver Alginate Dressing 11cm×11cm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9e10775b-d4c5-4d70-ad27-385e04311ecf
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:
26958868752020
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
16958868752023
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16958868752023
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
box
Item #3 - Device ID:
36958868752027
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
60
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
26958868752020
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 47474
Name: Exudate-absorbent dressing, hydrophilic-gel, 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, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It 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 while reducing microbial colonization within the dressing. 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:
K230190
Supplement Number:
000