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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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Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAR0MaxPlus2.5
Not in Commercial Distribution

  • M896MAR0MAXPLUS250 ()
  • M896MAR0MAXPLUS251 ()
MAR0MaxPlus2.5

  • Haematological concentrate system preparation kit, platelet concentration
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
LTN105-O
In Commercial Distribution

  • M896LTN105O1 ()
  • M896LTN105O0 ()


  • Bone marrow biopsy needle, single-use
Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
40-K10-0001
In Commercial Distribution

  • M89640K1000010 ()
  • M89640K1000011 ()
40-K10-0001

  • Haematological concentrate system preparation kit, platelet concentration
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 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
TissuGlu Surgical Adhesive
COHERA MEDICAL, INC.
TG100US
In Commercial Distribution

  • M690TG100US0 ()
  • M690TG100US3 ()
TG100US

  • Surgical internal adhesive/sealant, synthetic polymer
Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color White Size L
TOP QUALITY MANUFACTURING, INC.
W8840
In Commercial Distribution

  • TQ26W88402 ()
  • TQ26W88401 ()
  • TQ26W88400 ()
W8840

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color White Size S
TOP QUALITY MANUFACTURING, INC.
W8810
In Commercial Distribution

  • TQ26W88102 ()
  • TQ26W88101 ()
  • TQ26W88100 ()
W8810

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color White Size XS
TOP QUALITY MANUFACTURING, INC.
W8800
In Commercial Distribution

  • TQ26W88002 ()
  • TQ26W88001 ()
  • TQ26W88000 ()
W8800

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
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