Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca

GUDID 00856040008809

Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing cap

ARGENTUM MEDICAL, LLC

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00856040008809
• NIH Device Record Key: f63036d7-4d73-450d-aa21-0a406d57a94f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca
• Version Model Number: 5003G
• 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	00856040008793 [Primary]
GS1	00856040008809 [Package]; Contains: 00856040008793; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073547

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: 2023-06-20
• Device Publish Date: 2023-06-12

On-Brand Devices [Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca]

• 00856040008823: Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing cap (Spanish)
• 00856040008809: Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing cap