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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 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
Cruiser models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
CONVAID PRODUCTS, INC.
CX10T
In Commercial Distribution

  • 10840117400747 ()
904851

  • Transport wheelchair, collapsible
  • Attendant-only-propelled wheelchair, non-bariatric
Safari models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
CONVAID PRODUCTS, INC.
SFT12
In Commercial Distribution

  • 10840117400235 ()
900493

  • Transport wheelchair, collapsible
  • Attendant-only-propelled wheelchair, non-bariatric
Rodeo models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
CONVAID PRODUCTS, INC.
RD10
In Commercial Distribution

  • 10840117400198 ()
904340

  • Transport wheelchair, collapsible
  • Attendant-only-propelled wheelchair, non-bariatric
Flyer models are manual wheelchairs intended to provide mobility to a person with disabilities who is permanently or partially non-ambulatory and limited to a seated position.
CONVAID PRODUCTS, INC.
FL12
In Commercial Distribution

  • 10840117400105 ()
905088

  • Transport wheelchair, collapsible
  • Attendant-only-propelled wheelchair, non-bariatric
SteriTrak is a sterile, temporarily implantable Kirschner wire (K-wire) intended to be implanted into any bone for the purposes of providing an anchor for skeletal traction.
Arbutus Medical Inc
SteriTrak
In Commercial Distribution

  • 00844107000583 ()
  • 00844107000576 ()


  • Orthopaedic bone wire
This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.
SKYPRO ENTERPRISE LIMITED
SP01
In Commercial Distribution

  • 04897030537042 ()
  • 04897030530968 ()
FP3FNWH

  • Surgical/medical face mask, single-use
Skypro, SP01 Mask is intended to be used by healthcare personnel to protect themselves and patients from the transfer of microorganisms, body fluids, and particulate matter.
SKYPRO ENTERPRISE LIMITED
SP01
In Commercial Distribution

  • 04897030530982 ()
  • 04897030530975 ()
  • 04897030530999 ()
FP3FNWH

  • Surgical/medical face mask, single-use
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
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