Normlgel Ag 350450

GUDID 05032749040127

Silver Antimicrobial Wound Gel

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID05032749040127
NIH Device Record Key05549ecf-9b7e-4337-bf38-f23b1a47c9a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNormlgel Ag
Version Model NumberSilver Hydrogel
Catalog Number350450
Company DUNS770434090
Company NameADVANCED MEDICAL SOLUTIONS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105032749040127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-13
Device Publish Date2023-09-05

Devices Manufactured by ADVANCED MEDICAL SOLUTIONS LIMITED

05032749040851 - Melgisorb2025-04-22 Melgisorb Ag Antimicrobial Alginate Dressing, 5 x 5 cm
05032749040882 - Melgisorb2025-04-22 Melgisorb Ag Antimicrobial Alginate Dressing, 10 x 10 cm
05032749040912 - Melgisorb2025-04-22 Melgisorb Ag Antimicrobial Alginate Dressing, 15 x 15 cm
05032749040943 - Melgisorb2025-04-22 Melgisorb Ag Antimicrobial Alginate Dressing, 20 x 20 cm
05032749040974 - Melgisorb2025-04-22 Melgisorb Ag Antimicrobial Alginate Dressing, 3 x 44 cm
25032749041128 - ActivHeal2025-02-14 NON ADHESIVE FOAM TRILAM 15x15cm
15032749039166 - Actibride™2024-09-09 ActivHeal® Actibride™ Debridement Pad 11cmx18cm
15032749040605 - RAPONICEL™ 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 5x5CM

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.