Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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3.25mm diameter X 8mm length Engage Plus Bone Level Implant
OCO BIOMEDICAL INC
EngagePlus
In Commercial Distribution

  • D78532508ENGPLS0 ()
32508 Engage Plus

  • Screw endosteal dental implant, two-piece
Transfer Pack Container 600 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2023
Not in Commercial Distribution

  • 20811137010633 ()
  • 10811137010636 ()
  • 0FE04R2023 ()
  • 00811137010639 ()
4R2023

  • Blood/tissue storage/culture container
Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2004
Not in Commercial Distribution

  • 20811137010626 ()
  • 10811137010629 ()
  • 0FE04R2004 ()
  • 00811137010622 ()
4R2004

  • Blood/tissue storage/culture container
Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2001
Not in Commercial Distribution

  • 20811137010619 ()
  • 10811137010612 ()
  • 0FE04R2001 ()
  • 00811137010615 ()
4R2001

  • Blood/tissue storage/culture container
Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path
FENWAL, INC.
4R2024
Not in Commercial Distribution

  • 0FE04R2024 ()
  • 10811137010551 ()
  • 00811137010554 ()
  • 20811137010558 ()
4R2024

  • Blood/tissue storage/culture container
Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2014
Not in Commercial Distribution

  • 20811137010541 ()
  • 10811137010544 ()
  • 0FE04R2014 ()
  • 00811137010547 ()
4R2014

  • Blood/tissue storage/culture container
Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path
FENWAL, INC.
4R2032
Not in Commercial Distribution

  • 20811137010497 ()
  • 10811137010490 ()
  • 0FE04R2032 ()
  • 00811137010493 ()
4R2032

  • Blood/tissue storage/culture container
Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path
FENWAL, INC.
4R2027
Not in Commercial Distribution

  • 10811137010735 ()
  • 00811137010738 ()
  • 0FE04R2027 ()
4R2027

  • Blood/tissue storage/culture container
Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft
Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
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