Orcel Bilayered Cellular Matrix
by Forticell Bioscience PMA
Active
PMA P010016
Overview
The Orcel Bilayered Cellular Matrix is an interactive wound and burn dressing designed for clinical application. It is specifically indicated for the treatment of fresh, clean split thickness donor site wounds in burn patients.
This device is manufactured by Forticell Bioscience and has received FDA PMA authorization. It is categorized as a class 3 medical device for use in professional medical settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPCV | NumberP010016 | Date31 Aug 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- Dressing, wound and burn, interactive
- PMA Number
- FDA Product Code
- MGR
- Device Class
- Class III
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- APCV
Questions
What is the primary use of the Orcel Bilayered Cellular Matrix?
The device is indicated for the treatment of fresh, clean split thickness donor site wounds in patients who have sustained burns.
What type of medical device is Orcel?
Orcel is classified as an interactive wound and burn dressing, which is a specialized medical product designed to assist in the management of specific wound types.
Is the Orcel Bilayered Cellular Matrix FDA authorized?
Yes, the device has received FDA PMA authorization, which indicates it has undergone the premarket approval process required for class 3 medical devices.