BIAKOS™ Antimicrobial Skin & Wound Cleanser

GUDID 00860000939539

BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. BIAKOS™ is a broad-spectrum skin and wound cleanser that is safe to use.

Sanara Medtech Inc.

Antimicrobial wound irrigation solution

• Primary Device ID: 00860000939539
• NIH Device Record Key: fd358051-d637-4fcd-b952-a50647e8946a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIAKOS™ Antimicrobial Skin & Wound Cleanser
• Version Model Number: AWC0401
• 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	00860000939539 [Primary]
GS1	10860000939536 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160192

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: 2023-08-25
• Device Publish Date: 2023-08-17

On-Brand Devices [BIAKOS™ Antimicrobial Skin & Wound Cleanser]

• 20860000939557: BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and fore
• 00860000939539: BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and fore