FDA-Device2020-02-05Class II
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodo
Collagen Matrix Inc
Hazard
The products may have been packaged with an incorrect Instructions for Use.
Sold states
US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IL, MA, MD, MI, MN, NC, NJ, NY, OK, PA, SC, TX, UT, VA, and WA.
Affected count
192 total
Manufactured in
15 Thornton Rd, N/A, Oakland, NJ, United States
Products
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2020Don't want to check this manually?
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