Vaccines, Blood & Biologics

GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)

STN: BL 125400/0
Proper Name: Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
Trade Name: GINTUIT
Manufacturer: Organogenesis Incorporated
Indication: Is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.

Supporting Documents

Related Information

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 01/29/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.