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 Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial Wound hydrogel dressing, antimicrobial 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