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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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Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 1kg Traditional
In Commercial Distribution

  • 05056079040893 ()
AC2S05000

  • Denture base resin kit
Cold Cure Denture Base Powder
WRIGHT HEALTH GROUP LIMITED
Convertible CC 1kg Clear
In Commercial Distribution

  • 05056079040862 ()
AC2S05005

  • Denture base resin kit
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
200X25X8 MM, 40 CC
In Commercial Distribution

  • 00816986020518 ()
SGFS-040

  • Synthetic bone graft
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
100X25X8 MM, 20 CC
In Commercial Distribution

  • 00816986020501 ()
SGFS-020

  • Synthetic bone graft
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
50X25X8 MM, 10 CC
In Commercial Distribution

  • 00816986020495 ()
SGFS-010

  • Synthetic bone graft
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
25X25X8 MM, 5 CC
In Commercial Distribution

  • 00816986020488 ()
SGFS-005

  • Synthetic bone graft
IntelliSpace Critical Care and Anesthesia
Philips Medical Systems Hsg
IntelliSpace CC & Anesthesia J
Not in Commercial Distribution

  • 00884838113763 ()
866148

  • Medical equipment clinical data interfacing software
4 cc spindle drive syringe of BG Putty bioactive bone graft substitute
Prosidyan, Inc.
4800-0040
In Commercial Distribution

  • 00856879006106 ()
48000040

  • Bone matrix implant, synthetic, non-antimicrobial
6 cc spindle drive syringe of BG Putty bioactive bone graft substitute.
Prosidyan, Inc.
4800-0060
In Commercial Distribution

  • 00856879006090 ()
48000060

  • Bone matrix implant, synthetic, non-antimicrobial
11 cc spindle drive syringe of BG Putty bioactive bone graft substitute.
Prosidyan, Inc.
4800-0110
In Commercial Distribution

  • 00856879006083 ()
48000110

  • Bone matrix implant, synthetic, non-antimicrobial
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