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 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| customerservice@sanaramedtech.com | |
| Phone | 800-205-7719 |
| 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.
| 00860000939591 - BIAKOS™ Antimicrobial Wound Gel | 2025-03-06BIAKOS™ Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial PHMB. |
| 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 |
| 00860000939508 - Hycol® | 2024-11-08 HYCOL Hydrolyzed Collagen is Type I bovine hydrolyzed collagen and contains no additives. |
| 00850017274075 - CellerateRX Surgical | 2024-05-31 CellerateRX® Surgical Activated Collagen® Powder is Type I bovine hydrolyzed collagen and contains no additives. |
| 00850017274082 - CellerateRX Surgical | 2024-05-31 CellerateRX® Surgical Activated Collagen® Powder is Type I bovine hydrolyzed collagen and contains no additives. |
| 00850017274006 - BIASURGE™ Advanced Surgical Solution | 2023-11-03 BIASURGE Advanced Surgical Solution is a clear, colorless solution for use with lavage or preferred application method. The prod |
| 00860000939539 - BIAKOS™ Antimicrobial Skin & Wound Cleanser | 2023-08-25 BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, woun |
| 20860000939557 - BIAKOS™ Antimicrobial Skin & Wound Cleanser | 2023-06-28 BIAKOS™ Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, woun |
Trademark Results [BIAKOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIAKOS 88521849 not registered Live/Pending |
Sanara MedTech Inc. 2019-07-18 |
 BIAKOS 88521841 not registered Live/Pending |
Sanara MedTech Inc. 2019-07-18 |
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