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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 Hobbs Cytology Brush is intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.
HOBBS MEDICAL, INC.
4108
In Commercial Distribution

  • M84941080 ()
  • M84941082 ()
4108

  • Flexible endoscopic cytology brush, single-use
No Description
HOBBS MEDICAL, INC.
4101
In Commercial Distribution

  • M84941012 ()
  • M84941010 ()
4101

  • Saccamanno solution IVD
A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.
HOBBS MEDICAL, INC.
2190
In Commercial Distribution

  • M84921901 ()
  • M84921900 ()
2190

  • Endoscopic spray catheter, single-use
A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
HOBBS MEDICAL, INC.
2181
In Commercial Distribution

  • M84921811 ()
  • M84921810 ()
2181

  • Tracheobronchial suction/insufflation catheter, single-lumen
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / BZD / COC / M-AMP / OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7112-13
In Commercial Distribution

  • M90107RD7112130 ()
  • M90107RD7112131 ()

  • Length: 74 Millimeter
07RD7112-13

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of buprenorphine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7106
In Commercial Distribution

  • M90107RD71061 ()
  • M90107RD71060 ()

  • Length: 75 Millimeter
07RD7106

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BUP / MTD / OPI
LUMIQUICK DIAGNOSTICS, INC.
07RD7093-11A
In Commercial Distribution

  • M90107RD709311A1 ()
  • M90107RD709311A0 ()

  • Length: 75 Millimeter
07RD7093-11A

  • 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 / 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 / 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 / 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
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