COL-FID4 Care Collagen Wound Dressing

Basic Information

• Brand Name: COL-FID4 Care Collagen Wound Dressing
• Primary DI: M713COL2021
• Version / Model: COL202
• Catalog Number: COL202
• Company Name: FIDIA FARMACEUTICI SPA
• Labeler DUNS: 428453013
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-11-24
• Public Version: 1
• Public Version Date: 2025-12-02
• Public Version Status: New
• Public Device Record Key: 7af55c15-5d89-45ef-96e2-25e3122ab7d8

Device Description

COL-FID 4 CARE Collagen is a native 100% Bovine Type 1 collagen, which when applied to a wound surface, absorbs wound exudate, and maintains a moist wound environment to aid in the management of wound healing. COL-FID 4 Care Collagen Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, cuts, and abrasions. Each carton contains 5 dressings and each case contains 10 cartons.

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: No
• 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	Wound Dressing With Animal-Derived Material(S)	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	M713COL2020	HIBCC
Primary	M713COL2021	HIBCC
Package	M713COL20201	HIBCC	Carton	5	In Commercial Distribution