SILVERCEL 800112

GUDID 15051978002390

14-24APX Silver Hydro - Alginate

ADVANCED MEDICAL SOLUTIONS LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial

• Primary Device ID: 15051978002390
• NIH Device Record Key: ba00be0c-5d45-41a4-b766-600c5a8a66f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILVERCEL
• Version Model Number: Silver Alginate
• Catalog Number: 800112
• 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	15051978002390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081363

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: 2023-05-03
• Device Publish Date: 2023-04-25

On-Brand Devices [SILVERCEL]

• 15051978002499: 14-24APX LAM Silver Hydro-Alginate NA
• 15051978002482: 14-24APX LAM Silver Hydro-Alginate NA
• 15051978002475: 14-24APX LAM Silver Hydro-Alginate NA
• 15051978002468: 14-24APX LAM Silver Hydro-Alginate NA
• 15051978002369: 14-24APX Silver Hydro - Alginate
• 15051978002314: 14-24APX Silver Hydro - Alginate
• 15051978002284: 14-24APX Silver Hydro - Alginate
• 15051978002390: 14-24APX Silver Hydro - Alginate