HELICOLL

Basic Information

• Brand Name: HELICOLL
• Primary DI: 10860000744406
• Version / Model: HC2x2
• Catalog Number: HC2x2
• Company Name: ENCOLL CORP.
• Labeler DUNS: 962858049
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-07-11
• Public Version: 2
• Public Version Date: 2025-07-21
• Public Version Status: Update
• Public Device Record Key: b03a52d5-74e0-4898-8aa6-c315589d5c70

Device Description

HELICOLL is a biological, sterile, reconstituted bovine Type-I Collagen Sheet of 2x2 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGN	Dressing, Wound, Collagen	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00860000744409	GS1
Primary	10860000744406	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K040314	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 32 Degrees Celsius