Anasept Antimicrobial Wound Irrigation Solution filled in 16 oz. PET bottles wit

GUDID 10856040008448

Anasept Antimicrobial Wound Irrigation Solution filled in 16 oz. PET bottles with spikeable cap.

ARGENTUM MEDICAL, LLC

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• Primary Device ID: 10856040008448
• NIH Device Record Key: ce87f50a-b50a-48e4-a105-a7171b5f04da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anasept Antimicrobial Wound Irrigation Solution filled in 16 oz. PET bottles wit
• Version Model Number: 4160IC
• 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	00856040008441 [Primary]
GS1	10856040008448 [Package]; Contains: 00856040008441; 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

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