BIASURGE™ Advanced Surgical Solution

GUDID 00850017274006

BIASURGE Advanced Surgical Solution is a clear, colorless solution for use with lavage or preferred application method. The product contains PHMB as a preservative to reduce microbial growth within the packaging during shelf storage after the sterile seal has been broken.

Sanara Medtech Inc.

Antimicrobial wound irrigation solution

• Primary Device ID: 00850017274006
• NIH Device Record Key: d3d6b107-ef7a-4e40-8e78-e6a464788db9
• Commercial Distribution Discontinuation: 2026-09-04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIASURGE™ Advanced Surgical Solution
• Version Model Number: BAS-0101
• Company DUNS: 807043914
• Company Name: Sanara Medtech Inc.
• 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017274006 [Primary]
GS1	10850017274003 [Package]; Package: Case [6 Units]; Discontinued: 2023-09-07; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223377

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-03
• Device Publish Date: 2023-10-26

Devices Manufactured by Sanara Medtech Inc.

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• 00850017274006 - BIASURGE™ Advanced Surgical Solution: 2023-11-03BIASURGE Advanced Surgical Solution is a clear, colorless solution for use with lavage or preferred application method. The product contains PHMB as a preservative to reduce microbial growth within the packaging during shelf storage after the sterile seal has been broken.
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