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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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MediWorks - 06945087517017

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

  • 06945087517017 ()


  • Ophthalmic tonometer, manual

Custom Condoms - 00726893118881

Guac is Extra Condoms, Bag of 50 MTO
GLOBAL PROTECTION CORP.
BKU65
In Commercial Distribution

  • 80726893118887 ()
  • 00726893118881 ()


  • Basic male condom, Hevea-latex

Custom Condoms - 00726893118652

Love is Love Heart Condoms, Bag of 50
GLOBAL PROTECTION CORP.
BKU33
In Commercial Distribution

  • 80726893118658 ()
  • 00726893118652 ()


  • Basic male condom, Hevea-latex

ELITE - 00724995219901

ELITE Prone Positioner is ideal for spinal procedures.
STERIS CORPORATION
BF485
In Commercial Distribution

  • 00724995219901 ()
BF485

  • Operating table patient pressure distribution pad, reusable

BrainCheck Assess - 00860011154501

BrainCheck Assess is a digital cognitive assessment platform.
Braincheck, Inc.
2
In Commercial Distribution

  • 00860011154501 ()


  • Cognitive assessment software

Revian Lyte - 00862712000392

The Revian Lyte is a hair regrowth cap.
Revian, Inc.
10000-10011
In Commercial Distribution

  • 00862712000392 ()
10011

  • Hair growth laser device

Single-Use Video Bronchoscope - 06932503571128

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

DEXIS IXS Size 1 Sensor - D090101329140

This is a kit containing a medical device.
Dental Imaging Technologies Corporation
1.013.2914
In Commercial Distribution

10132914

  • Dental digital imaging sensor, intraoral

Coaxial Interventional Needle - 04262410680456

This needle is intended for puncture and injection.
ITP Innovative Tomography Products GmbH
KIM13/14T
In Commercial Distribution

  • 04262410680463 ()
  • 04262410680456 ()

  • Length: 144 Millimeter
  • Needle Gauge: 13 Gauge


  • Hypodermic needle, single-use

Coaxial Interventional Needle - 04262410680432

This needle is intended for puncture and injection.
ITP Innovative Tomography Products GmbH
KIM13/09T
In Commercial Distribution

  • 04262410680449 ()
  • 04262410680432 ()

  • Length: 94 Millimeter
  • Needle Gauge: 13 Gauge


  • Hypodermic needle, single-use
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