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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-XPress 100, 10cc is made using demineralized human bone mixed with poloxamer reverse phase medium. Trel-XPress 100 is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPRES110
In Commercial Distribution

  • M386XPRES1101 ()
  • 10381780112518 ()

  • 10cc
XPRES110

  • Bone matrix implant, human-derived
Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the ten (10) vial configuration.
IMMUCOR, INC.
0705410
In Commercial Distribution

  • 10888234001812 ()
0705410

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Gamma N-HANCE is used an additive to enhance reactivity in the detection of unexpected blood group antibodies. This product is Low Ionic Strength Saline (LISS) and is the three (3) vial configuration.
IMMUCOR, INC.
0705403
In Commercial Distribution

  • 10888234001805 ()
0705403

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
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 Pink.
SUN MEDICAL CO.,LTD.
MCL-011-C
Not in Commercial Distribution

  • 14560227799079 ()
  • 04560227799072 ()
  • 24560227799076 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
TS23US

  • Dental appliance fabrication material, thermoplastic
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 109 mm diameter x 30 mm depth, and coler type is Dark Pink.
SUN MEDICAL CO.,LTD.
MCL-013-B
Not in Commercial Distribution

  • 14560227799055 ()
  • 04560227799058 ()
  • 24560227799052 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 109 Millimeter
TS15US

  • Dental appliance fabrication material, thermoplastic
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 109 mm diameter x 30 mm depth, and coler type is Pink
SUN MEDICAL CO.,LTD.
MCL-011-B
Not in Commercial Distribution

  • 14560227799048 ()
  • 04560227799041 ()
  • 24560227799045 ()

  • Depth: 30 Micrometer
  • Outer Diameter: 109 Millimeter
TS13US

  • Dental appliance fabrication material, thermoplastic
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 109 mm diameter x 30 mm depth, and color type is Light Pink.
SUN MEDICAL CO.,LTD.
MCL-010-B
Not in Commercial Distribution

  • 14560227799031 ()
  • 04560227799034 ()
  • 24560227799038 ()

  • Depth: 30 Millimeter
  • Outer Diameter: 109 Millimeter
TS11US

  • Dental appliance fabrication material, thermoplastic
The 700 Single Lens Billboard Case base is fabricated from a low-density polypropylene plastic resin. The overall length is approximately 2.240 in., width is approximately 1.050 in. and height approximately 0.450 in. It has a single lens well and is paired with the Plain cap.
Paragon Vision Sciences, Inc.
700
In Commercial Distribution

  • B222700 ()
  • B2227009 ()


  • Contact lens case
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1908
In Commercial Distribution

  • 08809909406423 ()
OCT1908

  • Endoscopic electrosurgical electrode, monopolar, single-use
The Optimos™ Cystotome is intended for use as an electrosurgical accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst that is visibly bulging into the gastrointestinal tract. This device is supplied sterile and is intended for single use only.
TAEWOONGMEDICAL.CO.,LTD
OCT1907
In Commercial Distribution

  • 08809909406416 ()
OCT1907

  • Endoscopic electrosurgical electrode, monopolar, single-use
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