Device
Polyver Silver Alginate Dressing 3cm×4cm
Manufacturer
Roosin Medical Co., Ltd.
Model: 3cm×4cm DI: 16958868752030 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-04-29 Current Version: 2026-05-07
Description
Polyver Silver Alginate Dressing 3cm×4cm
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 57371da3-dcbc-409b-b2b0-b40e4f12ddf6
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: 26958868752037
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 5
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 16958868752030
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 16958868752030
Item #2 - Device ID Type: Primary
Item #2 - 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