Product characteristics

  • Procenta® is an acellular, highly hydrophilic, structural extracellular matrix
    derived from placental connective tissue.
  • Structural, human tissue allograft (FDA/TRG 361 status letter received).
  • Comprised of extracellular matrix scaffold that serves as a cover, to offer protection from the surrounding environment, and to retain fluid.
  • Allograft produced from healthy human donors. Intended for homologous use to supplement or replace damaged or inadequate connective tissue.
  • Stored at ambient temperature, ready for application in a sterile vial.
  • 4 year shelf life.
  • Available in 100mg and 200mg vial configuration.

BOX CONTENT

1

Outer Box that contains sterile packaged Procenta vial.

2

Vial is packaged in a single pouch.

3

Allograft Transplantation Record that must be completed and returned.

4

Allograft Return Card must be completed and sent with returned product.

PRODUCT HANDLING

1

Open product package & remove the Tyvek peel pouch containing the vial.

2

Using aseptic technique, peel open the Tyvek peel pouch and present sterile vial onto sterile field.

3

Open the vial and apply product as needed.

Product Information

The manufacturing of Procenta Tissue-based Allograft does not involve the combination of the placental tissue with another article, except for a placental storage agent.
After minimally manipulated processing, Procenta is terminally sterilized using E-beam irradiation to ensure recipient safety.
The Procenta Allograft processor is Lucina BioSciences, LLC. A proprietary, minimally manipulative manufacturing process (Nativus) ensures the original relevant characteristics of the tissue are retained.
The tissue bank is registered with the Food and Drug Administration (FDA).