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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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Coseal Surgical Sealant - 05413765404627

Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934071
In Commercial Distribution

  • 05413765404627 ()

  • Total Volume: 4 Milliliter
934071

  • Surgical internal adhesive/sealant, synthetic polymer

Coseal Surgical Sealant - 05413765404610

Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934070
In Commercial Distribution

  • 05413765404610 ()

  • Total Volume: 2 Milliliter
934070

  • Surgical internal adhesive/sealant, synthetic polymer

IMPLANET SPINE SYSTEM - 03607503501002

Monoaxial Pedicle Screw
IMPLANET
Monoaxial Pedicle Screw
In Commercial Distribution

  • 03607503501002 ()

  • diameter 5 mm lenght 35 mm
350100

  • Trans-facet-screw internal spinal fixation system, sterile

PEMF - SPINAL-STIM - 18257200133116

SUSPENDER, SPINAL STIM 5212/2212, ACCESSORY
Orthofix US LLC
655212-8001
In Commercial Distribution

  • 18257200133116 ()
5212 Suspender

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

PEMF - SPINAL-STIM - 18257200123926

5212CMD, DEMO, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, CM
Orthofix US LLC
655212-0006
In Commercial Distribution

  • 18257200123926 ()
5212CMD

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

PEMF - SPINAL-STIM - 18257200123902

5212CM, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, CM
Orthofix US LLC
655212-0005
In Commercial Distribution

  • 18257200123902 ()
5212CM

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

PEMF - SPINAL-STIM - 18257200105700

5212CED, DEMO, OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS
Orthofix US LLC
655212-0004
In Commercial Distribution

  • 18257200105700 ()
5212CED

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

PEMF - SPINAL-STIM - 18257200105694

5212CE, SHIP ASSY., OSTEOGENESIS STIMULATOR, SPINAL-STIM, OUS
Orthofix US LLC
655212-0003
In Commercial Distribution

  • 18257200105694 ()
5212CE

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

Not Applicable - 10195278901764

Software Pristina 9 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.9
In Commercial Distribution

  • 10195278901764 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

not applicable - 00195278866899

Software Pristina 8.4 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.6
In Commercial Distribution

  • 00195278866899 ()


  • Stationary mammographic x-ray system, digital
  • Mammographic x-ray system stereotactic unit
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