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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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Quantum Spinal Fixation System - 00846468088989

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-12-FXL
Not in Commercial Distribution


  • 12mm
10-12-FXL

  • Bone-screw internal spinal fixation system, non-sterile

Quantum Spinal Fixation System - 00846468088972

X-LINK, FIXED
Pioneer Surgical Technology, Inc.
10-11-FXL
Not in Commercial Distribution


  • 11mm
10-11-FXL

  • Bone-screw internal spinal fixation system, non-sterile

Sensor Pad - 00850014578145

Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor.
LUCERNO DYNAMICS, LLC
091220-018
In Commercial Distribution

  • 00850014578145 ()
  • 00850014578138 ()
091220-018

  • Hypoallergenic skin adhesive tape

Acarix CADScor Patch - 05700002223029

Acarix CADScor Patch, 20x patch in box. The intended use of the CADScor System is to record heart sounds, murmurs and vibration for calculation of a patient specific score, indicating the risk of coronary stenosis, as an aid in cardiac analysis and diagnosis.
Acarix A/S
ACP-1401
In Commercial Distribution

  • 05700002223012 ()
  • 05700002223029 ()
  • 05700002223036 ()
ACP-1401 (20x)

  • Phonocardiograph

Unity Total Knee System - 05055343894576

Pack of 5 Grub Screws
CORIN LTD
112.054.92
In Commercial Distribution

  • 05055343894576 ()
  • 05056139231865 ()
112.054.92

  • Orthopaedic bone screw, non-bioabsorbable, sterile

NA - 00848838097454

No Description
REMEL, INC.
R01822A
In Commercial Distribution

  • 00848838097454 ()
  • 00848838099922 ()


  • MRSA agar culture medium IVD, chromogenic

NA - 00848838093975

No Description
REMEL, INC.
R01196
In Commercial Distribution

  • 00848838093975 ()
  • 00848838099878 ()


  • Brain heart infusion (BHI) agar culture medium IVD

NA - 00848838093333

No Description
REMEL, INC.
R01187
In Commercial Distribution

  • 00848838093333 ()
  • 00848838099885 ()


  • Bile esculin/azide Enterococcus species agar culture medium IVD

NA - 00848838079160

No Description
REMEL, INC.
R01832
In Commercial Distribution

  • 00848838079160 ()
  • 00848838099939 ()


  • Chromogenic VRE agar culture medium IVD

NA - 00848838077135

No Description
REMEL, INC.
R01173
In Commercial Distribution

  • 00848838077135 ()
  • 00848838099427 ()


  • Brain heart infusion (BHI) agar culture medium IVD
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