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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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Trel X-Press 300 - 10381780112549

Trel-XPress 300, 10cc is made using demineralized human bone mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES310
In Commercial Distribution

  • 10381780112549 ()
  • M386XPRES3101 ()

  • 10cc
XPRES310

  • Bone matrix implant, human-derived

BRAEBON MediByte - B140MP8W0

The MediByte is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a warranty replacement unit.
Braebon Medical Corporation
MP8-W
In Commercial Distribution

  • B140MP8W0 ()
MP8-W

  • Polysomnograph

Canady Plasma GIT Side Fire Probe - B413AW4225400

The Canady Hybrid Plasma GIT Side Fire probe is an electrosurgical plasma probe that is 2.3 mm in diameter and 2.3 m long. The electrosurgical plasma probe is used to coagulate biological tissue.
US MEDICAL INNOVATIONS, LLC
AW-422540
In Commercial Distribution

  • B413AW4225400 ()


  • Inert gas-enhanced endoscopic electrosurgical electrode, single-use

Acrylic Block - 14560227799116

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-M
Not in Commercial Distribution

  • 14560227799116 ()
  • 04560227799119 ()
  • 24560227799113 ()

  • Depth: 35 Millimeter
  • Width: 192 Millimeter
  • Length: 232 Millimeter
TS33US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799109

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Pink.
SUN MEDICAL CO.,LTD.
MCL-011-M
Not in Commercial Distribution

  • 14560227799109 ()
  • 04560227799102 ()
  • 24560227799106 ()

  • Depth: 35 Millimeter
  • Width: 192 Millimeter
  • Length: 232 Millimeter
TS32US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799093

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 232 mm length x 192 mm width x 35 mm depth, and the color type is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-M
Not in Commercial Distribution

  • 14560227799093 ()
  • 04560227799096 ()
  • 24560227799090 ()

  • Depth: 35 Millimeter
  • Width: 192 Millimeter
  • Length: 232 Millimeter
TS31US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799086

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-C
Not in Commercial Distribution

  • 14560227799086 ()
  • 04560227799089 ()
  • 24560227799083 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
TS25US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799062

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of its circular cylindrical shaped product is 98.5 mm diameter x 30 mm depth, and the color type is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-C
Not in Commercial Distribution

  • 14560227799062 ()
  • 04560227799065 ()
  • 24560227799069 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
TS21US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799024

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-A
Not in Commercial Distribution

  • 14560227799024 ()
  • 04560227799027 ()
  • 24560227799021 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS05US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799017

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Pink.
SUN MEDICAL CO.,LTD.
MCL-011-A
Not in Commercial Distribution

  • 14560227799017 ()
  • 04560227799010 ()
  • 24560227799014 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS03US

  • Dental appliance fabrication material, thermoplastic

Acrylic Block - 14560227799000

Acrylic Block is a cured acrylic resin plate that is indicated for use to fabricate a denture base using a CAD/CAM system. The size of the product is 109 mm length x 109 mm width x 35 mm depth. The model of color is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-A
Not in Commercial Distribution

  • 14560227799000 ()
  • 04560227799003 ()
  • 24560227799007 ()

  • Depth: 35 Millimeter
  • Width: 109 Millimeter
  • Length: 109 Millimeter
TS01US

  • Dental appliance fabrication material, thermoplastic

NaviCam Small Bowel Capsule Endoscopy System - 06921010800531

The Locator is a portable magnetic scanning device with built-in rechargeable lithium battery. It is used to turn the capsule on before it is swallowed by the patient and can be used for detecting whether a capsule is inside the human body and probing its approximate position.
ANKON Technologies Co.,Ltd.
Locator/AKS-1
In Commercial Distribution

  • 06921010800531 ()
SB-US-2006

  • Video capsule endoscopy monitoring kit

Epredia - 00673693270427

ClearVue™ Mountant is a toluene-based rapid-drying mounting medium. It is miscible with all clearing agents including xylene substitutes. This mounting medium is optically clear and will not cause fading of stains even after prolonged storage. ClearVue Mountant is approved specifically for use with the ClearVue coverslipper.
RICHARD-ALLAN SCIENTIFIC COMPANY
ClearVue™ Mountant
In Commercial Distribution

  • 00673693270427 ()
4211

  • Microscopy mounting medium IVD

White PVA Foam Large - 00849405035138

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVALFOAM1
In Commercial Distribution

  • 00849405035138 ()

  • Length: 20 Centimeter
  • Width: 15 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

White PVA Foam Medium - 00849405035121

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVAFOAM1
In Commercial Distribution

  • 00849405035121 ()

  • Length: 15 Centimeter
  • Width: 10 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

White PVA Foam Small - 00849405035114

The PVA Foam is a Polyvinyl Alcohol that comes pre moistened with sterile water. It is a less adherent high tensile strength material that helps to promote grafts and is easy to place and remove from tunnels and undermined areas. It is a non-invasive, non-implantable medical device.
GENADYNE BIOTECHNOLOGIES INC.
XF-PVASFOAM1
In Commercial Distribution

  • 00849405035114 ()

  • Length: 7.5 Centimeter
  • Width: 10 Centimeter
  • Depth: 1 Centimeter


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Valtchev Uterine Mobilizer - 00627843701866

This item is the VUM-6 Tube for Dye Injection which is an integral part of the Valtchev Uterine Mobilizer, Model VUM-6. The tube has no stand alone functionality and is part of the VUM-6 device. This is a replacement part that can be ordered separately if needed.
Conkin Surgical Instruments Ltd
9A
In Commercial Distribution

  • 00627843701866 ()
9A

  • Uterine elevator

O2Vent Optima - 09351567000363

The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima Mini
In Commercial Distribution

  • 09351567000363 ()
O2VBM

  • Mandible-repositioning sleep-disordered breathing orthosis

O2Vent Optima - 09351567000035

The O2Vent Optima is a removable medical device that is fitted in the patient’s mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima
In Commercial Distribution

  • 09351567000035 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

Walker Holder - 00606509800020

A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. The Walker Holder is an accessory that mounts to a medical device to hold walkers.
Pride Mobility Products Corp
Walker Holder
In Commercial Distribution

  • 00606509800020 ()
N/A

  • Wheelchair crutch/walking stick holder
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