Dual Layer Membrane
Awarded Q Code Q4262
| Dual Layer Impax Membrane is a sterile allograft designed for optimal wound covering and protection during the treatment of wounds. | |
| Dual Layer Impax Membrane Key Features and Properties | |
| • Provides a protective wound covering
• Dehydrated extracellular matrix acts as a scaffold supporting the native tissue • Adheres easily to wounds, including those with irregular surfaces • Immune privileged and angiogenic • 5-year shelf life at ambient temperature storage |
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| IMPAX Ordering Information | ||
|---|---|---|
| PRODUCT NUMBER | SIZE | TOTAL UNITS (PER CM2) |
| IMP-0202 | 2×2 | 4 |
| IMP-0203 | 2×3 | 6 |
| IMP-0404 | 4×4 | 16 |
| IMP-0406 | 4×6 | 24 |
| IMP-0408 | 4×8 | 32 |
| IMP-1020 | 10×20 | 200 |
| IMP-1520 | 15×20 | 300 |
Dual Layer Impax Membrane is an amniotic membrane allograft derived from a prescreened mother with a planned C-section delivery. Dual Layer Impax Membrane is manufactured in compliance with FDA regulations and AATB guidance. The membrane is minimally processed to preserve the native structure of the tissue, dehydrated, and terminally sterilized. Dual Layer Impax Membrane is confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271. |