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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.
4104
In Commercial Distribution

  • M84941040 ()
  • M84941042 ()
4104

  • Flexible endoscopic cytology brush, single-use
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
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
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
TissuGlu Surgical Adhesive
COHERA MEDICAL, INC.
TG100US
In Commercial Distribution

  • M690TG100US0 ()
  • M690TG100US3 ()
TG100US

  • Surgical internal adhesive/sealant, synthetic polymer
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
AXTi163620
In Commercial Distribution

  • M711AXTI1636201 ()
  • M711AXTI1636200 ()

  • Height: 16 Millimeter
  • Width: 36 Millimeter
  • Angle: 20 degree
AXTi163620

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
AXTi163614
In Commercial Distribution

  • M711AXTI1636141 ()
  • M711AXTI1636140 ()

  • Height: 16 Millimeter
  • Width: 36 Millimeter
  • Angle: 14 degree
AXTi163614

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
AXTi163608
In Commercial Distribution

  • M711AXTI1636081 ()
  • M711AXTI1636080 ()

  • Height: 16 Millimeter
  • Width: 36 Millimeter
  • Angle: 8 degree
AXTi163608

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
AXTi163030
In Commercial Distribution

  • M711AXTI1630301 ()
  • M711AXTI1630300 ()

  • Height: 16 Millimeter
  • Width: 30 Millimeter
  • Angle: 30 degree
AXTi163030

  • Metallic spinal interbody fusion cage
Ti 6Al 4V (ELI); Hydroxyapatite
Innovasis, Inc.
AXTi163020
In Commercial Distribution

  • M711AXTI1630201 ()
  • M711AXTI1630200 ()

  • Height: 16 Millimeter
  • Width: 30 Millimeter
  • Angle: 20 degree
AXTi163020

  • Metallic spinal interbody fusion cage
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