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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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The PE Mix Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-6560-01
In Commercial Distribution

  • 30850009370243 ()
  • 10850009370249 ()
03-6560-01

  • Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
ORTHOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. ORTHOVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
277500
In Commercial Distribution

  • 08437027710025 ()


  • Synovial fluid supplementation medium
MONOVISC is a viscoelastic solution of high-molecular weight hyaluronan. Hyaluronan acts as a lubricant and shock absorber in the joint. MONOVISC is used to relieve knee pain due to osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
SAIMA GLOBAL FARMA S.L.
277515
In Commercial Distribution

  • 08437027710018 ()


  • Synovial fluid supplementation medium
single use RF head coil for MRI imaging during neuro MRI-guided FUS treatment. a part of 1.5T neuro kit for USA (SET000937)
INSIGHTEC LTD
Neuro Head coil
In Commercial Distribution

  • 07290015461184 ()
ASC002258-AA

  • Therapeutic oncological/gynaecological ultrasound system
STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Xvivo Perfusion AB
19004
In Commercial Distribution

  • 07350069520036 ()

  • Total Volume: 500 Milliliter
19004

  • Donor-organ/tissue/cell preservation solution
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
BAXTER HEALTHCARE CORPORATION
508602
In Commercial Distribution

  • 35413765589653 ()
  • 05413765589652 ()
  • 75413765589651 ()

  • Width: 5 Inch
  • Length: 3 Inch
508602

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
BAXTER HEALTHCARE CORPORATION
638001
In Commercial Distribution

  • 35413765589646 ()
  • 05413765589645 ()
  • 75413765589644 ()

  • Width: 2.5 Inch
  • Length: 3 Inch
638001

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
BAXTER HEALTHCARE CORPORATION
664101
In Commercial Distribution

  • 35413765589639 ()
  • 05413765589638 ()

  • Length: 3 Inch
  • Width: 5 Inch
664101

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
BAXTER HEALTHCARE CORPORATION
664201
In Commercial Distribution

  • 35413765589622 ()
  • 05413765589621 ()
  • 75413765589620 ()

  • Length: 3 Inch
  • Width: 5 Inch
664201

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).
BAXTER HEALTHCARE CORPORATION
430102
In Commercial Distribution

  • 35413765589615 ()
  • 05413765589614 ()

  • Length: 5 Inch
  • Width: 6 Inch
430102

  • Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
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