BIAKOS™ Antimicrobial Wound Gel

GUDID 00860000939591

BIAKOS™ Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB.

Sanara Medtech Inc.

Wound hydrogel dressing, antimicrobial

• Primary Device ID: 00860000939591
• NIH Device Record Key: 4a95b22b-c70c-4ca3-a0c9-8acc4d5ac157
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIAKOS™ Antimicrobial Wound Gel
• Version Model Number: AWG0101-12
• Company DUNS: 807043914
• Company Name: Sanara Medtech Inc.
• Device Count: 12
• 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: false
• 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: true

Customer Support Contacts

• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com
• Phone: 800-205-7719
• Email: customerservice@sanaramedtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000939591 [Unit of Use]
GS1	10860000939598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192527

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: 2025-03-06
• Device Publish Date: 2025-02-26

Devices Manufactured by Sanara Medtech Inc.

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• 00860000939591 - BIAKOS™ Antimicrobial Wound Gel: 2025-03-06 BIAKOS™ Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antim
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