FDA-Device2019-05-29Class II
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid i
Collagen Matrix, Inc.
Hazard
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Sold states
Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
Affected count
45 units -US;170 units OUS
Manufactured in
110 Commerce Dr, N/A, Allendale, NJ, United States
Products
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2019Don't want to check this manually?
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