HELICOLL HC0.8x1.6

GUDID 00860000744461

HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 0.8x1.6 inches intended for the treatment of Wounds, Burns, and Ulcers. HELICOLL collagen sheet is free of contaminants and US Patented for further unique physiological modification. HELICOLL collagen is biodegradable and highly bioactive matrix for capillary growth and tissue regeneration.

ENCOLL CORP.

Collagen wound matrix dressing

• Primary Device ID: 00860000744461
• NIH Device Record Key: 7fcd0022-1374-4ed4-9775-0f8d38a2d2b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELICOLL
• Version Model Number: HC0.8x1.6
• Catalog Number: HC0.8x1.6
• Company DUNS: 962858049
• Company Name: ENCOLL CORP.
• Device Count: 2
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com
• Phone: 510 396 8581
• Email: guna@encoll.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000744461 [Unit of Use]
GS1	10860000744468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040314

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: 2023-05-02
• Device Publish Date: 2023-04-24

On-Brand Devices [HELICOLL]

• 00860000744447: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 13 mm dia disc
• 00860000744430: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 8x8 inches inte
• 00860000744423: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 4x4 inches inte
• 00860000744416: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x4 inches inte
• 00860000744409: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x2 inches inte
• 00860000744485: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.6x1.6 inches
• 00860000744478: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 1.2x1.6 inches
• 00860000744461: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 0.8x1.6 inches
• 00860000744454: HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 25 mm dia disc