BIATAIN 376539980

GUDID 05032749032627

14-24AP Silver Alginate II

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 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: 05032749032627
• NIH Device Record Key: 0f592e7d-3ca3-4e6e-8eef-a5eefdbe01ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIATAIN
• Version Model Number: Alginate Ag
• Catalog Number: 376539980
• Company DUNS: 770434090
• Company Name: ADVANCED MEDICAL SOLUTIONS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	05032749032627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090453

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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by ADVANCED MEDICAL SOLUTIONS LIMITED

• 15032749040605 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 5x5CM
• 15032749040612 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 10X10CM
• 15032749040629 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 10X12CM
• 15032749040636 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 15X15CM
• 15032749040643 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 20X30CM
• 15032749040650 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 2.5X30.5CM
• 15032749040667 - RAPONICEL™: 2024-05-08 ACTIVHEAL® RAPONICEL™ ULTRA 2X46CM
• 07332551227340 - Melgisorb: 2023-10-30 14-24AP Silver Alginate II