Wound Care
SkinTemp® II
100% non-hydrolyzed Type I bovine native collagen sheets preserving the native triple-helical protein structure for superior wound healing.
Manufacturer
Human BioSciences®
Classification
Class II Medical Device, FDA 510(k) cleared
510(k) Number
K122325
FDA Product Code
KGN
Storage
Ambient / Room Temp
Available Size & HCPCS
| Size | HCPCS |
|---|---|
| 2″×2″ & 3″×4″ | A6021 |
| 7″×7″ & 8″×12″ | A6023 |
✓ Medicare reimbursable
Overview
SkinTemp® II is a collagen wound dressing in sheet format manufactured from 100% non-hydrolyzed Type I bovine native collagen. Using proprietary Kollagen™ technology, it preserves the native triple-helical protein structure for enhanced stability. The breathable sheet format provides superior fluid control while maintaining a moist wound environment.
Key Features & Benefits
- Breathable sheet format for superior fluid management
- 100% non-hydrolyzed Type I bovine native collagen
- Proprietary Kollagen™ technology preserves triple-helical structure
- Supports all four phases of wound healing
- Superior molecular stability throughout the healing process
- No cold chain required, ships standard ground
Indications for Use
SkinTemp 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
SkinTemp® II is a Class II Medical Device, FDA 510(k) cleared (K122325). The product provides a structural collagen matrix 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.
