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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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Hobbs Medical Cytology Brush - M84941100

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.
4110
In Commercial Distribution

  • M84941100 ()
  • M84941102 ()
4110

  • Flexible endoscopic cytology brush, single-use

Hobbs Medical Cytology Brush - M84941080

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

Hobbs Medical Cytology Brush - M84941060

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.
4106
In Commercial Distribution

  • M84941060 ()
  • M84941062 ()
4106

  • Flexible endoscopic cytology brush, single-use

Hobbs Medical Cytology Brush - M84941040

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.
4104
In Commercial Distribution

  • M84941040 ()
  • M84941042 ()
4104

  • Flexible endoscopic cytology brush, single-use

Hobbs Medical Cytology Brush - M84941020

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.
4102
In Commercial Distribution

  • M84941020 ()
  • M84941022 ()
4102

  • Flexible endoscopic cytology brush, single-use

Hobbs Medical Saccomanno Cell Transport System - M84941010

No Description
HOBBS MEDICAL, INC.
4101
In Commercial Distribution

  • M84941012 ()
  • M84941010 ()
4101

  • Saccamanno solution IVD

Hobbs Medical Mistifier Spray Catheter - M84921910

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.
2191
In Commercial Distribution

  • M84921911 ()
  • M84921910 ()
2191

  • Endoscopic spray catheter, single-use

Hobbs Medical Mistifier Spray Catheter - M84921900

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

Hobbs Aspiration Catheter - M84921820

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.
2182
In Commercial Distribution

  • M84981821 ()
  • M84921820 ()
2182

  • Irrigation catheter, single-lumen

Hobbs Aspiration Catheter - M84921810

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

Coeur Nemoto - M902552000

200mL Disposable Syringe
COEUR, INC.
C855-5200
In Commercial Distribution

  • M902552006 ()
  • M902552000 ()

  • Total Volume: 200 Milliliter
C855-5200

  • Angiographic syringe

Coeur nemoto - M902551780

100mL/100mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes
COEUR, INC.
C855-5178
In Commercial Distribution

  • M902551786 ()
  • M902551780 ()

  • Total Volume: 100 Milliliter
C855-5178

  • Angiographic syringe

Coeur Nemoto - M902551740

100mL /100mL Disposable CT Dual Syringe Pack includes (1) Y-Set / (1) Check Valve / (1) J-Tube
COEUR, INC.
C855-5174
In Commercial Distribution

  • M902551746 ()
  • M902551740 ()

  • Total Volume: 100 Milliliter
C855-5174

  • Angiographic syringe

Coeur Nemoto - M902551550

100mL/50mL CT Dual Syringe Pack Includes (1) Y-set /(1) Check Valve / (2) Fill Spikes
COEUR, INC.
C855-5155
In Commercial Distribution

  • M902551556 ()
  • M902551550 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 100 Milliliter
C855-5155

  • Angiographic syringe

Coeur Nemoto - M902551500

150mL Disposable Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5150
In Commercial Distribution

  • M902551506 ()
  • M902551500 ()

  • Total Volume: 150 Milliliter
C855-5150

  • Angiographic syringe

Coeur Nemoto - M902551250

125mL Disposable Angiographic Syringe Includes (1) Fill Tube
COEUR, INC.
C855-5125
In Commercial Distribution

  • M902551256 ()
  • M902551250 ()

  • Total Volume: 125 Milliliter
C855-5125

  • Angiographic syringe

Coeur Nemoto - M902551060

100mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Spike
COEUR, INC.
C855-5106
In Commercial Distribution

  • M902551066 ()
  • M902551060 ()

  • Total Volume: 100 Milliliter
C855-5106

  • Angiographic syringe

Coeur Nemoto - M902551020

100mL Disposable CT Syringe Includes (1) 60” Coiled Extension Line / (1) Fill Tube
COEUR, INC.
C855-5102
In Commercial Distribution

  • M902551026 ()
  • M902551020 ()
C855-5102

  • Angiographic syringe

Coeur Nemoto - M902551010

100mL Disposable Syringe includes (1) fill tube
COEUR, INC.
C855-5101
In Commercial Distribution

  • M902551016 ()
  • M902551010 ()

  • Total Volume: 100 Milliliter
C855-5101

  • Angiographic syringe

Coeur Nemoto - M902551000

100mL Disposable Syringe
COEUR, INC.
C855-5100
In Commercial Distribution

  • M902551006 ()
  • M902551000 ()

  • Total Volume: 100 Milliliter
C855-5100

  • Angiographic syringe

Coeur Nemoto - M902550790

50mL /50mL Disposable MR Dual Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (2) Spikes
COEUR, INC.
C855-5079
In Commercial Distribution

  • M902550796 ()
  • M902550790 ()

  • Total Volume: 50 Milliliter
C855-5079

  • Angiographic syringe

Coeur Nemoto - M902550590

50mL Disposable MR Syringe Pack includes (1) 96” Y-Set / (2) Check Valves / (1) Spike
COEUR, INC.
C855-5059
In Commercial Distribution

  • M902550590 ()
  • M902550596 ()

  • Total Volume: 50 Milliliter
C855-5059

  • Angiographic syringe

QuickProfile™ Drugs of Abuse Test Cup - M90174046II0

Immunoassay for the detection of the following drug substance(s) in human urine: Selection of panel numbers between 1 to 9 from AMP / BAR / BZD / COC / M-AMP / MTD / OPI / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
74046-II
In Commercial Distribution

  • M90174046II0 ()
  • M90174046II1 ()

  • Length: 74 Millimeter
74046-II

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

QuickProfile™ Drugs of Abuse Panel 7 Test Card - M90107RD718402A0

Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BAR / BZD / COC / OPI-2000 / PCP / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7184-02A
In Commercial Distribution

  • M90107RD718402A1 ()
  • M90107RD718402A0 ()

  • Length: 75 Millimeter
07RD7184-02A

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

QuickProfile™ Drugs of Abuse Test Cup - M90107RD7112130

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

QuickProfile™ Buprenorphine Test Card - M90107RD71060

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

QuickProfile™ Buprenorphine Test Strip - M90107RD71050

Immunoassay for the detection of buprenorphine in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7105
In Commercial Distribution

  • M90107RD71051 ()
  • M90107RD71050 ()

  • Length: 75 Millimeter
07RD7105

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

QuickProfile™ Oxycodone Test Strip - M90107RD71000

Immunoassay for the detection of oxycodone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7100
In Commercial Distribution

  • M90107RD71001 ()
  • M90107RD71000 ()

  • Length: 75 Millimeter
07RD7100

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

QuickProfile™ Drugs of Abuse Panel 3 Test Card - M90107RD709311A0

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

QuickProfile™ Drugs of Abuse Panel 10 Test - M90107RD7073150

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
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