Silver-sept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispens

GUDID 00856040008854

Silver-sept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispensing cap

ARGENTUM MEDICAL, LLC

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00856040008854
• NIH Device Record Key: af0c3577-0494-45d5-9561-073c87382c87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silver-sept Antimicrobial Skin and Wound Gel filled in 1.5 oz. tube with dispens
• Version Model Number: 3015S
• Company DUNS: 091449079
• Company Name: ARGENTUM MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856040008830 [Primary]
GS1	00856040008854 [Package]; Contains: 00856040008830; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062212

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30

Devices Manufactured by ARGENTUM MEDICAL, LLC

• 10653599002251 - Men's Liberty: 2024-06-17 Men's Liberty for iMEDicare, (box of 30)
• 10653599002190 - CathGrip: 2024-06-10 CathGrip Single Strap, Small, Non-Sterile, No Wipes, Brazil
• 10653599002206 - CathGrip: 2024-06-10 CathGrip Double Strap, Large, Non-Sterile, No Wipes, Brazil
• 10653599002213 - CathGrip: 2024-06-10 CathGrip Double Strap, Medium, Non-Sterile, No Wipes, Brazil
• 10653599002220 - CathGrip: 2024-06-10 CathGrip Single Strap, Large, Non-Sterile, No Wipes, Brazil
• 10653599002237 - CathGrip: 2024-06-10 CathGrip Oval, Small, Non-Sterile, No Wipes, Brazil
• 10653599002244 - CathGrip: 2024-06-10 CathGrip Oval, Large, Non-Sterile, No Wipes, Brazil
• 10653599000547 - CathGrip: 2024-04-11 CathGrip Single Strap Large, Non-Sterile, No Alcohol