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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 Size SM, Height 5, 5° Lordosis
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100030 ()

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

  • Cervical total intervertebral disc prosthesis, modular
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 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 Size SM, Height 4
Nuvasive, Inc.
A
In Commercial Distribution

  • 00843285100009 ()

  • Height: 4 Millimeter
SM-4

  • Cervical total intervertebral disc prosthesis, modular
The SpiroScout SP is a PC based system designed to measure and record FVC and SV Spiro recordings for adult and paediatric patients. Measurements are made with the SpiroScout ultrasound sensor. The SpiroScout sensor is supplied with either a disposable single- use ScoutTube, or a disposable single- use PFT Bacterial filter mouthpiece assembly. A ScoutTube or PFT filter is used for every patient to help prevent patient cross contamination. Spiroscout SP is technically identical to Spiroscout and is intended exclusively for use with Schiller's AT 102
Ganshorn Medizin Electronic GmbH
A
In Commercial Distribution

  • 04250972300134 ()
013400562

  • Diagnostic spirometer, professional
Vista Clean multi-purpose contact lens solution cleans, rinses, disinfects, stores, and conditions contact lenses. Vista Clean is compatible for use with any lens type including RGP lenses, scleral lenses, hybrid lenses, and soft lenses including silicone hydrogel.
Nomax, Inc.
A
In Commercial Distribution

  • 00351801021030 ()
  • 00351801021047 ()
AH-3665-00000

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
Vista Clean multi-purpose contact lens solution cleans, rinses, disinfects, stores, and conditions contact lenses. Vista Clean is compatible for use with any lens type including RGP lenses, scleral lenses, hybrid lenses, and soft lenses including silicone hydrogel.
Nomax, Inc.
A
In Commercial Distribution

  • 00351801021016 ()
  • 00351801021023 ()
AH-3664-00000

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
Washer Caddy Case
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809401499633 ()
FA.CS.2000

  • General internal orthopaedic fixation system implantation kit
Implant Caddy Case for 5.5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809401499626 ()
FA.CS.0055

  • General internal orthopaedic fixation system implantation kit
Implant Caddy Case for 5.0
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809401499619 ()
FA.CS.0050

  • General internal orthopaedic fixation system implantation kit
Implant Caddy Case for 4.5
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809401499602 ()
FA.CS.0045

  • General internal orthopaedic fixation system implantation kit
AL Case
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809401499596 ()
FA.CS.1000

  • General internal orthopaedic fixation system implantation kit
SIJ screw caddy
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809401499589 ()
SI.IN.0100

  • General internal orthopaedic fixation system implantation kit
VARIABLE SELF DRILLING SCREW 3.8 X 18
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718679 ()
RC.VD.3818

  • Spinal fixation plate, non-bioabsorbable
VARIABLE SELF DRILLING SCREW 3.8 X 16
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718662 ()
RC.VD.3816

  • Spinal fixation plate, non-bioabsorbable
VARIABLE SELF DRILLING SCREW 3.8 X 14
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718655 ()
RC.VD.3814

  • Spinal fixation plate, non-bioabsorbable
VARIABLE SELF DRILLING SCREW 3.8 X 12
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718648 ()
RC.VD.3812

  • Spinal fixation plate, non-bioabsorbable
VARIABLE SELF DRILLING SCREW 3.8 X 10
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718631 ()
RC.VD.3810

  • Spinal fixation plate, non-bioabsorbable
FIXED SELF DRILLING SCREW 3.8X18
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718624 ()
RC.FD.3818

  • Spinal fixation plate, non-bioabsorbable
FIXED SELF DRILLING SCREW 3.8X16
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809375718617 ()
RC.FD.3816

  • Spinal fixation plate, non-bioabsorbable
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