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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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Simplify® Cervical Artificial Disc - 00843285100023

Simplify® Cervical Artificial Disc Size SM, Height 5
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100023 ()

  • Height: 5 Millimeter
SM-5

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100016

Simplify® Cervical Artificial Disc Size SM, Height 4, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100016 ()

  • Height: 4 Millimeter
  • Angle: 5 degree
SM-4L

  • Cervical total intervertebral disc prosthesis, modular

Simplify® Cervical Artificial Disc - 00843285100009

Simplify® Cervical Artificial Disc Size SM, Height 4
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100009 ()

  • Height: 4 Millimeter
SM-4

  • Cervical total intervertebral disc prosthesis, modular

Synvisc - 05060497630048

No Description
PHARMACEUTICAL HEALTH LIMITED
5 Count
In Commercial Distribution

  • 5060497630055 ()
  • 05060497630048 ()


  • Synovial fluid supplementation medium

Supartz - 05060497630031

No Description
PHARMACEUTICAL HEALTH LIMITED
NA
In Commercial Distribution

  • 05060497630031 ()


  • Synovial fluid supplementation medium

Orthovisc - 05060497630024

No Description
PHARMACEUTICAL HEALTH LIMITED
NA
In Commercial Distribution

  • 05060497630024 ()


  • Synovial fluid supplementation medium

Euflexxa - 05060497630017

No Description
PHARMACEUTICAL HEALTH LIMITED
NA
In Commercial Distribution

  • 05060497630017 ()


  • Synovial fluid supplementation medium

Synvisc - 05060497630000

No Description
PHARMACEUTICAL HEALTH LIMITED
NA
In Commercial Distribution

  • 05060497630000 ()


  • Synovial fluid supplementation medium

metra Liver Perfusion Circuit Pack - 05060462240043

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146_US
In Commercial Distribution

  • 05060462240043 ()


  • Liver donor-organ preservation/transport system

OrganOx metra - 05060462240029

The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours. The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146
In Commercial Distribution

  • 05060462240029 ()


  • Liver donor-organ preservation/transport system
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