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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This needle is intended for puncture and injection.
ITP Innovative Tomography Products GmbH
KIM25/03N
In Commercial Distribution

  • 04262410680012 ()
  • 04262410680005 ()

  • Needle Gauge: 25 Gauge
  • Length: 30 Millimeter


  • Hypodermic needle, single-use
This is a kit containing a medical device.
Dental Imaging Technologies Corporation
1.013.2914
Not in Commercial Distribution

  • EKAV101329140 ()
10132914

  • Dental digital imaging sensor, intraoral
Tonometer is indicated for Intraocular Pressure (IOP) measurement .
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
T170(T)
In Commercial Distribution

  • 06945087517024 ()


  • Ophthalmic tonometer, manual
Tonometer is indicated for Intraocular Pressure (IOP) measurement .
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
T170(R)
In Commercial Distribution

  • 06945087517017 ()


  • Ophthalmic tonometer, manual
Single-Use Video Bronchoscope:Maximum insertion portion width is 6.3mm.
Micro-Tech (Nanjing) Co., Ltd.
SVB33001
In Commercial Distribution

  • 16932503571132 ()
  • 06932503571135 ()
  • 26932503571139 ()

  • Outer Diameter: 6.3 Millimeter
  • Pore Size: 2.8 Millimeter
  • Catheter Working Length: 600 Millimeter


  • Flexible video bronchoscope, single-use
Single-Use Video Bronchoscope:Maximum insertion portion width is 5.5mm.
Micro-Tech (Nanjing) Co., Ltd.
SVB22001
In Commercial Distribution

  • 16932503571125 ()
  • 06932503571128 ()
  • 26932503571122 ()

  • Outer Diameter: 5.5 Millimeter
  • Pore Size: 2.2 Millimeter
  • Catheter Working Length: 600 Millimeter


  • Flexible video bronchoscope, single-use
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000C
In Commercial Distribution

  • 06928798600360 ()


  • Hair growth laser device
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000E
In Commercial Distribution

  • 06928798600346 ()


  • Hair growth laser device
It is hair growing system for OTC use
Xuzhou Kernel Medical Equipment Co., Ltd.
KN-8000D
In Commercial Distribution

  • 06928798600339 ()


  • Hair growth laser device
Guac is Extra Condoms, Bag of 50 MTO
GLOBAL PROTECTION CORP.
BKU65
In Commercial Distribution

  • 80726893118887 ()
  • 00726893118881 ()


  • Basic male condom, Hevea-latex
Love is Love Heart Condoms, Bag of 50
GLOBAL PROTECTION CORP.
BKU33
In Commercial Distribution

  • 80726893118658 ()
  • 00726893118652 ()


  • Basic male condom, Hevea-latex
ELITE Prone Positioner is ideal for spinal procedures.
STERIS CORPORATION
BF485
In Commercial Distribution

  • 00724995219901 ()
BF485

  • Operating table patient pressure distribution pad, reusable
The Revian Lyte is a hair regrowth cap.
Revian, Inc.
10000-10011
In Commercial Distribution

  • 00862712000392 ()
10011

  • Hair growth laser device
The ook cocoon is an AC-powered medical bed.
Umano Medical Inc
FL36 ook cocoon
In Commercial Distribution

  • 00670482000111 ()
  • 00670482000173 ()
  • 10670482000170 ()
FL36

  • Basic electric hospital bed
The ook snow MH is a Medical bed.
Umano Medical Inc
FL36 ook snow MH
In Commercial Distribution

  • 00670482000166 ()
  • 00670482000104 ()
  • 10670482000163 ()
FL36

  • Basic electric hospital bed
The ook cocoon is an AC-powered medical bed.
Umano Medical Inc
FL36 ook cocoon
In Commercial Distribution

  • 10670482000941 ()
  • 00670482000944 ()
FL36

  • Basic electric hospital bed
The ook snow is an AC-powered medical bed.
Umano Medical Inc
FL36 ook snow
In Commercial Distribution

  • 10670482000927 ()
  • 00670482000920 ()
FL36

  • Basic electric hospital bed
Is a device used to measure human temparature
SILEX GLOBAL LLC
Infrared ear/forehead thermometer YK-IRT1
In Commercial Distribution

  • 00856324008181 ()


  • Infrared patient thermometer, ear/skin
BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software
The Riester diagnostic light is used for examination.
Rudolf Riester GmbH
5131-02
In Commercial Distribution

  • 04045396198517 ()
5131-02

  • Hand-held examination/treatment light
The Riester diagnostic light is used for examination.
Rudolf Riester GmbH
5131-01
In Commercial Distribution

  • 04045396198500 ()
5131-01

  • Hand-held examination/treatment light
The Riester diagnostic light is used for examination.
Rudolf Riester GmbH
5130-02
In Commercial Distribution

  • 04045396198494 ()
5130-02

  • Hand-held examination/treatment light
The Riester diagnostic light is used for examination.
Rudolf Riester GmbH
5130-01
In Commercial Distribution

  • 04045396198487 ()
5130-01

  • Hand-held examination/treatment light
This device is used to drill a hole.
AJU PHARM. CO., LTD.
Fixone.I.S-D/B300
In Commercial Distribution

  • 08800039100656 ()


  • Fluted surgical drill bit, single-use
ASSURE patient app is a component of CareStation.
Kestra Medical Technologies, Inc.
80601-001
In Commercial Distribution

80601-001

  • Medical equipment clinical data interfacing software
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Rod Ø5.5 L225
In Commercial Distribution

  • 03700406335542 ()
ODRR55225

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Rod Ø5.5 L185
In Commercial Distribution

  • 03700406335535 ()
ODRR55185

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø7 L50
In Commercial Distribution

  • 03700406335412 ()
ODSS55750

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø7 L45
In Commercial Distribution

  • 03700406335405 ()
ODSS55745

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø7 L40
In Commercial Distribution

  • 03700406335399 ()
ODSS55740

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø7 L35
In Commercial Distribution

  • 03700406335382 ()
ODSS55735

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø7 L30
In Commercial Distribution

  • 03700406335375 ()
ODSS55730

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø6 L50
In Commercial Distribution

  • 03700406335368 ()
ODSS55650

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø6 L45
In Commercial Distribution

  • 03700406335351 ()
ODSS55645

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø6 L40
In Commercial Distribution

  • 03700406335344 ()
ODSS55640

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø6 L35
In Commercial Distribution

  • 03700406335337 ()
ODSS55635

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø6 L30
In Commercial Distribution

  • 03700406335320 ()
ODSS55630

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø5 L50
In Commercial Distribution

  • 03700406335313 ()
ODSS55550

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø5 L45
In Commercial Distribution

  • 03700406335306 ()
ODSS55545

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø5 L40
In Commercial Distribution

  • 03700406335290 ()
ODSS55540

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø5 L35
In Commercial Distribution

  • 03700406335283 ()
ODSS55535

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Polyaxial spondylolisthesis screw Ø5 L30
In Commercial Distribution

  • 03700406335276 ()
ODSS55530

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Rod Ø5.5 L255
In Commercial Distribution

  • 03700406335115 ()
ODRR55255

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Curved rod Ø5.5 L115
In Commercial Distribution

  • 03700406335108 ()
ODPBR55115

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Rod Ø5.5 L135
In Commercial Distribution

  • 03700406335092 ()
ODRR55135

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Rod Ø5.5 L155
In Commercial Distribution

  • 03700406335085 ()
ODRR55155

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Curved rod Ø5.5 L105
In Commercial Distribution

  • 03700406335078 ()
ODPBR55105

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Curved rod Ø5.5 L95
In Commercial Distribution

  • 03700406335061 ()
ODPBR55095

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Curved rod Ø5.5 L85
In Commercial Distribution

  • 03700406335054 ()
ODPBR55085

  • Bone-screw internal spinal fixation system, non-sterile
The Odalys is a pedicle screw spinal system.
KISCO INTERNATIONAL
Curved rod Ø5.5 L75
In Commercial Distribution

  • 03700406335047 ()
ODPBR55075

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