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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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Precise Sapphire - M896PRSAP0600

Precise Sapphire - 60 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-060
In Commercial Distribution

  • M896PRCSAP0601 ()
  • M896PRSAP0600 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Sapphire - M896PRCSAP1200

Precise Sapphire - 120 mL LR Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-SAP-120
In Commercial Distribution

  • M896PRCSAP1201 ()
  • M896PRCSAP1200 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Diamond - M896PRCDIA1200

Precise Diamond - 120 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-120
In Commercial Distribution

  • M896PRCDIA1201 ()
  • M896PRCDIA1200 ()


  • Haematological concentrate system preparation kit, platelet concentration

Precise Diamond - M896PRCDIA0600

Precise Diamond - 60 mL LP Kit
ARTERIOCYTE MEDICAL SYSTEMS, INC.
PRC-DIA-060
In Commercial Distribution

  • M896PRCDIA0600 ()
  • M896PRCDIA0601 ()


  • Haematological concentrate system preparation kit, platelet concentration

Autologous Serum Dispenser Kit - M896MSD4050

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.
MSD405
Not in Commercial Distribution

  • M896MSD4050 ()
  • M896MSD4051 ()
MSD405

  • Haematological concentrate system preparation kit, platelet concentration

Ratio Dispenser Kit - M896MRD5050

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.
MRD505
In Commercial Distribution

  • M896MRD5050 ()
  • M896MRD5051 ()
MRD505

  • Haematological concentrate system preparation kit, platelet concentration

Basic Platelet Separator Kit - M896MDK3050

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.
MDK305
In Commercial Distribution

  • M896MDK3050 ()
  • M896MDK3051 ()
MDK305

  • Haematological concentrate system preparation kit, platelet concentration

Magellan Complete Disposable Kit - M896MDK300JPN0

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MDK300-JPN
In Commercial Distribution

  • M896MDK300JPN0 ()
  • M896MDK300JPN1 ()


  • Haematological concentrate system preparation kit, platelet concentration

Autologous Platelet Separator Disposables Kit - M896MDK3000

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.
MDK300
In Commercial Distribution

  • M896MDK3000 ()
  • M896MDK3001 ()
MDK300

  • Haematological concentrate system preparation kit, platelet concentration

MAR0Max Plus 5cc Convenience Kit - M896MAR0MAXPLUS50

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.
MAR0MaxPlus5
Not in Commercial Distribution

  • M896MAR0MAXPLUS50 ()
  • M896MAR0MAXPLUS51 ()
MAR0MaxPlus5

  • Haematological concentrate system preparation kit, platelet concentration

MAR0Max Plus 2.5cc Convenience Kit - M896MAR0MAXPLUS250

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

Lightning Needle - M896LTN105O0

No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
LTN105-O
In Commercial Distribution

  • M896LTN105O1 ()
  • M896LTN105O0 ()


  • Bone marrow biopsy needle, single-use

Surgical tools for erythrocyte & marrow preparation kit - M89640K1000010

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

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 - 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

TissuGlu Surgical Adhesive - M690TG100US0

TissuGlu Surgical Adhesive
COHERA MEDICAL, INC.
TG100US
In Commercial Distribution

  • M690TG100US0 ()
  • M690TG100US3 ()
TG100US

  • Surgical internal adhesive/sealant, synthetic polymer

BioGrip Nitrile Examination Gloves - TQ26W88401

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

BioGrip Nitrile Examination Gloves - TQ26W88101

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

BioGrip Nitrile Examination Gloves - TQ26W88001

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

Top Quality Manufacturing, Inc. - TQ26SP275131

Sterilization Pouches See Through Self Sealing w/ In-Built Indicator Item # SP2-7513 200 Pouches Single Use
TOP QUALITY MANUFACTURING, INC.
See Through Self Sealing w/ In-Built Indicator
In Commercial Distribution

  • TQ26SP275135 ()
  • TQ26SP275131 ()
  • TQ26SP275130 ()
SP2-7513

  • Sterilization packaging, single-use

Top Quality Manufacturing, Inc. - TQ26SP252111

Sterilization Pouches See Through Self Sealing w/ In-Built Indicator Item # SP2-5211 200 Pouches Single Use
TOP QUALITY MANUFACTURING, INC.
See Through Self Sealing w/ In-Built Indicator
In Commercial Distribution

  • TQ26SP252115 ()
  • TQ26SP252111 ()
  • TQ26SP252110 ()
SP2-5211

  • Sterilization packaging, single-use

Top Quality Manufacturing, Inc. - TQ26SP235101

Sterilization Pouches See Through Self Sealing w/ In-Built Indicator Item # SP2-3510 200 Pouches Single Use
TOP QUALITY MANUFACTURING, INC.
See Through Self Sealing w/ In-Built Indicator
In Commercial Distribution

  • TQ26SP235105 ()
  • TQ26SP235101 ()
  • TQ26SP235100 ()
SP2-3510

  • Sterilization packaging, single-use

Neoshield Polychloroprene Examination Gloves - TQ26PCP301

Polychloroprene Gloves Not made with Natural Rubber Latex Examination Gloves Color Pink Size M
TOP QUALITY MANUFACTURING, INC.
PCP30
In Commercial Distribution

  • TQ26PCP302 ()
  • TQ26PCP301 ()
  • TQ26PCP300 ()
PCP30

  • Polychloroprene examination/treatment glove, non-powdered

Neoshield Polychloroprene Examination Gloves - TQ26PC301

Polychloroprene Gloves Not made with Natural Rubber Latex Examination Gloves Color Green Size M
TOP QUALITY MANUFACTURING, INC.
PC30
In Commercial Distribution

  • TQ26PC302 ()
  • TQ26PC301 ()
  • TQ26PC300 ()
PC30

  • Polychloroprene examination/treatment glove, non-powdered

BioGrip Nitrile Examination Gloves - TQ26P88301

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Pink Size M
TOP QUALITY MANUFACTURING, INC.
P8830
In Commercial Distribution

  • TQ26P88302 ()
  • TQ26P88301 ()
  • TQ26P88300 ()
P8830

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

BioGrip Nitrile Examination Gloves - TQ26P88101

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Pink Size S
TOP QUALITY MANUFACTURING, INC.
P8810
In Commercial Distribution

  • TQ26P88102 ()
  • TQ26P88100 ()
  • TQ26P88101 ()
P8810

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

Jeannie Nitrile Examination Gloves - TQ26P7301

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Pink Size M
TOP QUALITY MANUFACTURING, INC.
P730
In Commercial Distribution

  • TQ26P7302 ()
  • TQ26P7301 ()
  • TQ26P7300 ()
P730

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

Jeannie Nitrile Examination Gloves - TQ26P7001

Nitrile Gloves Not made with Natural Rubber Latex Examination Gloves Color Pink Size XS
TOP QUALITY MANUFACTURING, INC.
P700
In Commercial Distribution

  • TQ26P7002 ()
  • TQ26P7001 ()
  • TQ26P7000 ()
P700

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

TruGrip Pink Latex Examination Gloves - TQ26P26301

Natural Rubber Latex Examination Gloves Color Pink Size M
TOP QUALITY MANUFACTURING, INC.
P2630
In Commercial Distribution

  • TQ26P26302 ()
  • TQ26P26301 ()
  • TQ26P26300 ()
P2630

  • Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial
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