Wound Care
Medifil® II
Flowable collagen matrix for wound bed preparation and granulation tissue formation.
Manufacturer
Human BioSciences®
Classification
Class II Medical Device, FDA 510(k) cleared
FDA Product Code
KGN
Storage
Ambient / Room Temp
Available Size & HCPCS
| Size | HCPCS |
|---|---|
| 1 oz tube | A6010 |
| 3 oz tube | A6010 |
✓ Medicare reimbursable
Overview
Medifil® II is a flowable collagen matrix derived from 100% non-hydrolyzed Type I bovine native collagen. Its gel formulation allows precise application to irregular wound beds, promoting a moist healing environment and supporting granulation tissue formation across all phases of wound healing.
Key Features & Benefits
- Flowable gel format for precise wound bed application
- 100% non-hydrolyzed Type I bovine native collagen
- Conforms to irregular wound geometries
- Maintains moist wound environment
- Supports granulation tissue formation
- No cold chain required, ships standard ground
Indications for Use
Medifil II is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.
Mechanism of Action
Medifil® II is a Class II Medical Device, FDA 510(k) cleared. The product provides a flowable collagen scaffold for wound management. Ridge Biologics does not make claims regarding healing rates, wound closure outcomes, or therapeutic effects. Clinical use should be based on healthcare provider judgment and in accordance with manufacturer labeling.
Regulatory & Compliance
Regulatory Framework
21 CFR 878.4022
Reimbursement
Medicare reimbursable, all sizes
Shipping
No cold chain: standard ground
Distributor License
Ridge Biologics, Utah DOPL
Refer to the manufacturer’s package insert for complete indications, contraindications, warnings, precautions, and instructions for use. Ridge Biologics is an authorized distributor and does not modify, manipulate, or repackage products. Distribution to licensed healthcare providers only.
