RAPONICEL™ 9040646

GUDID 15032749040643

ACTIVHEAL® RAPONICEL™ ULTRA 20X30CM

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID15032749040643
NIH Device Record Key5f0370ff-e034-49b2-91e6-9fcbb00e80da
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAPONICEL™
Version Model NumberALGINATE PHMB
Catalog Number9040646
Company DUNS770434090
Company NameADVANCED MEDICAL SOLUTIONS LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
GS115032749040643 [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 Date2024-05-08
Device Publish Date2024-04-30

On-Brand Devices [RAPONICEL™ ]

15032749040667ACTIVHEAL® RAPONICEL™ ULTRA 2X46CM
15032749040650ACTIVHEAL® RAPONICEL™ ULTRA 2.5X30.5CM
15032749040643ACTIVHEAL® RAPONICEL™ ULTRA 20X30CM
15032749040636ACTIVHEAL® RAPONICEL™ ULTRA 15X15CM
15032749040629ACTIVHEAL® RAPONICEL™ ULTRA 10X12CM
15032749040612ACTIVHEAL® RAPONICEL™ ULTRA 10X10CM
15032749040605ACTIVHEAL® RAPONICEL™ ULTRA 5x5CM
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