RAPONICEL™ 9040660

GUDID 15032749040667

ACTIVHEAL® RAPONICEL™ ULTRA 2X46CM

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 ID	15032749040667
NIH Device Record Key	b3ee5c93-1119-420a-8947-faa0ae36a84d
Commercial Distribution Status	In Commercial Distribution
Brand Name	RAPONICEL™
Version Model Number	ALGINATE PHMB
Catalog Number	9040660
Company DUNS	770434090
Company Name	ADVANCED MEDICAL SOLUTIONS LIMITED
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15032749040667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213473

FDA Product Code

FRO	Dressing, Wound, Drug

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-08
Device Publish Date	2024-04-30

On-Brand Devices [RAPONICEL™ ]

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