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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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The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 120mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006946 ()

  • 6.5mm x 120mm
1456-6520

  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Orthopaedic bone wire
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 115mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006939 ()

  • 6.5mm x 115mm
1456-6515

  • Orthopaedic bone wire
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 110mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006922 ()

  • 6.5mm x 110mm
1456-6510

  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Orthopaedic bone wire
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 105mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006915 ()

  • 6.5mm x 105mm
1456-6505

  • Orthopaedic bone wire
  • Orthopaedic bone screw, non-bioabsorbable, sterile
The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5mm x 100mm Support Beam Implant & Instrument Kit
In Commercial Distribution

  • 00850310006908 ()

  • 6.5mm x 100mm
1456-6500

  • Orthopaedic bone screw, non-bioabsorbable, sterile
  • Orthopaedic bone wire
HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
Qingdao Hightop Biotech Co., Ltd.
Cassette
In Commercial Distribution

  • 16935091670003 ()
  • 06935091670006 ()
  • 26935091670000 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
BIOMERICA, INC.
1048-25
Not in Commercial Distribution

  • 08305901048253 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
Fluoride containing dentin cleaning agent to desensitize and clean a prepared tooth prior to placement of an amalgam restoration or placement of a crown &/or bridge.
HEALTHDENT'L, LLC
HG10010
In Commercial Distribution

  • D799HG100100 ()

  • Total Volume: 10 Milliliter
HG10010

  • Dental coating, tooth-desensitizing
The EZ-hCGTM Urine test is a one-step immunoassay for the rapid, qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy.
BIOMERICA, INC.
1048-25
In Commercial Distribution

  • 00083059104851 ()


  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, kit, immunochromatographic test (ICT), rapid
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1109
In Commercial Distribution

  • EKAV100311090 ()
31 ES

  • Dental power tool system handpiece, line-powered
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