Hycol®

GUDID 00860000939508

HYCOL Hydrolyzed Collagen is Type I bovine hydrolyzed collagen and contains no additives.

Sanara Medtech Inc.

Collagen wound matrix dressing

• Primary Device ID: 00860000939508
• NIH Device Record Key: 671e0309-1127-45ce-a449-c2a75931fe8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hycol®
• Version Model Number: HCP0110
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000939508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955506

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

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: 2024-11-08
• Device Publish Date: 2024-10-31

Devices Manufactured by Sanara Medtech Inc.

• 00860000939508 - Hycol®: 2024-11-08HYCOL Hydrolyzed Collagen is Type I bovine hydrolyzed collagen and contains no additives.
• 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