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 device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
No Description
AALTO SCIENTIFIC
K898M-5
In Commercial Distribution

  • B085K898M50 ()


  • Multiple urine analyte IVD, control
No Description
AALTO SCIENTIFIC
K897M-5
In Commercial Distribution

  • B085K897M50 ()


  • Multiple urine analyte IVD, control
No Description
Bion Enterprises, Ltd.
QRP-6314
Not in Commercial Distribution

  • B110QRP63140 ()
QRP-6314

  • Multiple-genus respiratory virus antigen IVD, control
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / PCP
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-15
In Commercial Distribution

  • M90107RD7073151 ()
  • M90107RD7073150 ()

  • Length: 75 Millimeter
07RD7073-15

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / OPI / THC / PCP / OXY
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-09
In Commercial Distribution

  • M90107RD7073091 ()
  • M90107RD7073090 ()

  • Length: 75 Millimeter
07RD7073-09

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / BUP / COC / M-AMP / MTD / OPI / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-08
In Commercial Distribution

  • M90107RD7073081 ()
  • M90107RD7073080 ()

  • Length: 75 Millimeter
07RD7073-08

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / M-AMP / MTD / OPI / OXY / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-04
In Commercial Distribution

  • M90107RD7073041 ()
  • M90107RD7073040 ()

  • Length: 75 Millimeter
07RD7073-04

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI / OXY / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-03
In Commercial Distribution

  • M90107RD7073031 ()
  • M90107RD7073030 ()

  • Length: 75 Millimeter
07RD7073-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BUP / BZD / COC / M-AMP / MTD / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7073-01A
In Commercial Distribution

  • M90107RD707301A1 ()
  • M90107RD707301A0 ()

  • Length: 75 Millimeter
07RD7073-01A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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