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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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Web based software
MYCARDIO LLC
8
Not in Commercial Distribution

  • B315SLEEPIMAGECOM0 ()


  • Multiple physiological signal amplifier
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
8
Not in Commercial Distribution

  • M68980801D080 ()
80-801-D

  • Blood donor set, single-pack
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 8°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-08T-STR
In Commercial Distribution

  • M697X08042301908TSTR1 ()

  • Width: 42 Millimeter
  • Height: 19 Millimeter
  • Angle: 8 degree
  • Length: 30 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-08-STR
In Commercial Distribution

  • M697X08042301508STR1 ()

  • Length: 30 Millimeter
  • Angle: 8 degree
  • Width: 42 Millimeter
  • Height: 15 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 11mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423011-08-STRX
In Commercial Distribution

  • M697X08042301108STRX1 ()

  • Height: 11 Millimeter
  • Angle: 8 degree
  • Length: 30 Millimeter
  • Width: 42 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 11mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423011-08-STR
In Commercial Distribution

  • M697X08042301108STR1 ()

  • Length: 30 Millimeter
  • Width: 42 Millimeter
  • Angle: 8 degree
  • Height: 11 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 8°, 11mm, PC
Xtant Medical Holdings, Inc.
X080-423011-08PC
In Commercial Distribution

  • M697X08042301108PC1 ()

  • Angle: 8 degree
  • Height: 11 Millimeter
  • Length: 30 Millimeter
  • Width: 42 Millimeter


  • Polymeric spinal interbody fusion cage
Integra® Jarit® Walther Female Dilator-Catheter, 5-5/8", 30 French
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
X304441
In Commercial Distribution

  • M274X3044411 ()
  • 10381780406570 ()

  • 5-5/8"
  • Catheter Gauge: 30 French
X304441

  • Urethral sound, reusable
9 7/8" Scoville Ruptured Disc Curette, Curved Forward, 30 Degree
Surgical Direct, Inc.
SD914633104
In Commercial Distribution

  • B382SD9146331040 ()
SD914633104

  • Orthopaedic osteotome
John Day Periosteal Elevator, 8", Angled 30° At Cup, 6mm Cup
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
R8907
Not in Commercial Distribution

  • M274R89071 ()
  • 10381780194446 ()
R8907

  • Neurosurgical bone flap elevator
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