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.
TRU300
In Commercial Distribution

  • M896TRU3000 ()
  • M896TRU3001 ()
TRU300

  • Haematological concentrate system preparation kit, platelet concentration
MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
TRU100
In Commercial Distribution

  • M896TRU1001 ()
  • M896TRU1000 ()
TRU100

  • Haematological concentrate system centrifuge
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
RO-310
Not in Commercial Distribution

  • M896RO3101 ()
  • M896RO3100 ()
RO-310

  • Haematological concentrate system preparation kit, platelet concentration
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
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
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
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MDK300-JPN
In Commercial Distribution

  • M896MDK300JPN0 ()
  • M896MDK300JPN1 ()


  • Haematological concentrate system preparation kit, platelet concentration
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
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
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.
MAR0MaxPlus10
Not in Commercial Distribution

  • M896MAR0MAXPLUS100 ()
  • M896MAR0MAXPLUS101 ()
MAR0MaxPlus10

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR0Max80
In Commercial Distribution

  • M896MAR0MAX800 ()
  • M896MAR0MAX801 ()
MAR0Max80

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR0880
In Commercial Distribution

  • M896MAR08800 ()
  • M896MAR08801 ()
MAR0880

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01-O-80
In Commercial Distribution

  • M896MAR01O800 ()
  • M896MAR01O801 ()
MAR01-O-80

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01-O-25
In Commercial Distribution

  • M896MAR01O250 ()
  • M896MAR01O251 ()
MAR01-O-25

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01-BTI-45
Not in Commercial Distribution

  • M896MAR01BTI450 ()
  • M896MAR01BTI451 ()
MAR01-BTI-45

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01-ATS
In Commercial Distribution

  • M896MAR01ATS0 ()
  • M896MAR01ATS1 ()
MAR01-ATS

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01-AO
Not in Commercial Distribution

  • M896MAR01AO0 ()
  • M896MAR01AO1 ()
MAR01-AO

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01-60
Not in Commercial Distribution

  • M896MAR01600 ()
  • M896MAR01601 ()
MAR01-60

  • Haematological concentrate system preparation kit, platelet concentration
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.
MAR01
In Commercial Distribution

  • M896MAR010 ()
  • M896MAR011 ()
MAR01

  • Haematological concentrate system preparation kit, platelet concentration
MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
ARTERIOCYTE MEDICAL SYSTEMS, INC.
MAG100
In Commercial Distribution

  • M896MAG1001 ()
  • M896MAG1000 ()
MAG100

  • Haematological concentrate system centrifuge
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
LTN80-O
In Commercial Distribution

  • M896LTN80O1 ()
  • M896LTN80O0 ()


  • Bone marrow biopsy needle, single-use
No Description
ARTERIOCYTE MEDICAL SYSTEMS, INC.
LTN45-O
In Commercial Distribution

  • M896LTN45O1 ()
  • M896LTN45O0 ()


  • Bone marrow biopsy needle, single-use
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.
COS320
Not in Commercial Distribution

  • M896COS3200 ()
  • M896COS3201 ()
COS320

  • Haematological concentrate system preparation kit, platelet concentration
Cell Point Disposable Kit with 45mm Lightning Needle
ARTERIOCYTE MEDICAL SYSTEMS, INC.
CLPT-PK-101-45
In Commercial Distribution

  • M896CLPTPK101451 ()
  • M896CLPTPK101450 ()


  • Haematological concentrate system preparation kit, platelet concentration
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.
BOS360
Not in Commercial Distribution

  • M896BOS3600 ()
  • M896BOS3601 ()
BOS360

  • Haematological concentrate system preparation kit, platelet concentration
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.
AMS350
In Commercial Distribution

  • M896AMS3500 ()
  • M896AMS3501 ()
AMS350

  • Haematological concentrate system preparation kit, platelet concentration
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.
AMS310
In Commercial Distribution

  • M896AMS3101 ()
  • M896AMS3100 ()
AMS310

  • Haematological concentrate system preparation kit, platelet concentration
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.
AMS300
In Commercial Distribution

  • M896AMS3001 ()
  • M896AMS3000 ()
AMS300

  • Haematological concentrate system preparation kit, platelet concentration
An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).
HOBBS MEDICAL, INC.
G1120040
In Commercial Distribution

  • M849G11200400 ()
  • M849G11200401 ()
4581-U

  • Inert gas-enhanced endoscopic electrosurgical electrode, reusable
No Description
HOBBS MEDICAL, INC.
4650
In Commercial Distribution

  • M84946501 ()
  • M84946500 ()
4650

  • Endoscopic procedure air/water valve, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4577OLY
In Commercial Distribution

  • M8494577OLY0 ()
  • M8494577OLY1 ()
4577OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4575OLY
In Commercial Distribution

  • M8494575OLY0 ()
  • M8494575OLY1 ()
4575OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4575
In Commercial Distribution

  • M84945750 ()
  • M84945751 ()
4575

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4572OLY
In Commercial Distribution

  • M8494572OLY0 ()
  • M8494572OLY1 ()
4572OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4571OLY
In Commercial Distribution

  • M8494571OLY0 ()
  • M8494571OLY1 ()
4571OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4570OLY
In Commercial Distribution

  • M8494570OLY0 ()
  • M8494570OLY1 ()
4570OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4567OLY
In Commercial Distribution

  • M8494567OLY0 ()
  • M8496567OLY1 ()
4567OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4565OLY
In Commercial Distribution

  • M8494565OLY0 ()
  • M8494565OLY1 ()
4565OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4564OLY
In Commercial Distribution

  • M8494564OLY0 ()
  • M8494564OLY1 ()
4564OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4564
In Commercial Distribution

  • M84945640 ()
  • M84945641 ()
4564

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4563
In Commercial Distribution

  • M84945630 ()
  • M84945631 ()
4563

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4562
In Commercial Distribution

  • M84945620 ()
  • M84945621 ()
4562

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4560OLY
In Commercial Distribution

  • M8494560OLY0 ()
  • M8494560OLY1 ()
4560OLY

  • Flexible polypectomy snare, single-use
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4560
In Commercial Distribution

  • M84945600 ()
  • M84945601 ()
4560

  • Flexible polypectomy snare, single-use
The Hobbs Microbiology 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 inside a plastic tube, whose distal end is equipped with plastic bristles for harvesting and protecting mucosal cells, e.g., during endoscopy. This is a single-use device.
HOBBS MEDICAL, INC.
4320
In Commercial Distribution

  • M84943201 ()
  • M84943200 ()
4320

  • Flexible endoscopic cytology brush, single-use
The Nasal Cytology Brush consists of bristles at the distal end which is then set into a handle that is intended to collect cells from the nasal passages. The cells are used for histopathological analysis. This is a single-use device.
HOBBS MEDICAL, INC.
4291
In Commercial Distribution

  • M84942912 ()
  • M84942910 ()
4291

  • General-purpose cytology brush
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.
4206
In Commercial Distribution

  • M84942060 ()
  • M84942062 ()
4206

  • 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.
4112
In Commercial Distribution

  • M84941120 ()
  • M84941122 ()
4112

  • 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.
4110
In Commercial Distribution

  • M84941100 ()
  • M84941102 ()
4110

  • Flexible endoscopic cytology brush, single-use
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