Restorigin™ is a Dual Layer Amniotic Membrane
- Restorigin™ is a placental tissue allograft that may be used as a protective barrier in wound care applications. The natural properties of amniotic tissue provide mechanical protection to support the management of acute and chronic wounds.
- This is homologous use only because serving as a natural covering and offering protection from the surrounding environment are the inherent basic functions of amniotic membrane.
- Proprietary processing of the tissue retains the original relevant characteristics of native amniotic membrane.
- Dehydrated, packaged, and terminally sterilized. Stored at ambient temperature with a 2-year shelf life.
- HCPCS: Q4191
Restorigin™ meets all criteria to be compliant with Human Cell, Tissue and Tissue -Based Products (HCT/P)that are regulated solely under section 361 of the Public Health Service Act and under 21 CFR Part 1271 as stated by a letter from the Tissue Reference Group.
NOTE: Amniotic tissue allografts are not intended to diagnose, treat, cure or prevent any disease. Please consult your doctor to see if tissue allograft is right for you. No medical advice has been offered herein. None of these statements have been evaluated by the FDA.