Silver-sept Antimicrobial Skin and Wound Gel filled in a 3 oz. tube with dispens

GUDID 00856040008878

Silver-sept Antimicrobial Skin and Wound Gel filled in a 3 oz. tube with dispensing cap

ARGENTUM MEDICAL, LLC

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• Primary Device ID: 00856040008878
• NIH Device Record Key: ab35b6e0-8918-43b2-a164-fa3fb4c4ab88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silver-sept Antimicrobial Skin and Wound Gel filled in a 3 oz. tube with dispens
• Version Model Number: 3003S
• 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	00856040008861 [Primary]
GS1	00856040008878 [Package]; Contains: 00856040008861; Package: CASE [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

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