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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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SIGNAFUSE Bioactive Bone Graft - 00816986020495

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 - 00816986020488

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 - 00884838113763

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

HEPRO.US 0.3ml/cc 29G x 5/16" - 00850578007464

HEPRO.US Insulin Syringes attached needle 0.3ml/cc 29Gx 5/16" Box 100
HEPRO.US INC.
BX 0.3ml/cc 29G x 5/16"
In Commercial Distribution

  • 00850578007464 ()
  • 85057800746401 ()


  • Insulin syringe/needle, basic

HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe - 00850578007020

HEPRO.US 5 ml/cc 23 G x 1 1/2" Single Syringe
HEPRO.US INC.
SINGLE - 5 ml/cc 23G x 1 1/2"
In Commercial Distribution

  • 00850578007020 ()


  • General-purpose syringe, single-use

HEPRO.US Hypodermic Needle 10ml/cc 18G x 1” - 00854427007599

HEPRO.US Hypodermic Needle 10ml/cc 18G x 1”-100pcs 6 Boxes Case
HEPRO.US INC.
CT - 10ml/cc 18G x 1"
In Commercial Distribution

  • 00854427007599 ()
  • 85442700759902 ()


  • General-purpose syringe, single-use

Typenex Wound Drainage - 00851878008847

10 mm Flat Perforated, 3/4 size Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0402PK1
In Commercial Distribution

  • 00851878008854 ()
  • 00851878008847 ()


  • Closed-wound drainage kit

Typenex Wound Drainage - 00851878008762

7 mm Flat Perforated, 3/4 size Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0401PK1
In Commercial Distribution

  • 00851878008779 ()
  • 00851878008762 ()


  • Closed-wound drainage kit

FIBERGRAFT BG Putty-GPS - 00856879006106

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

FIBERGRAFT BG Putty-GPS - 00856879006090

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
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