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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.
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.
MAR0845
In Commercial Distribution

  • M896MAR08450 ()
  • M896MAR08451 ()
MAR0845

  • 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.
MAR02-O-80
Not in Commercial Distribution

  • M896MAR02O800 ()
  • M896MAR02O801 ()
MAR02-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.
MAR02-O-45
Not in Commercial Distribution

  • M896MAR02O450 ()
  • M896MAR02O451 ()
MAR02-O-45

  • Haematological concentrate system preparation kit, platelet concentration
Scar and Laser Gel
IMPLANTECH ASSOCIATES, INC.
14 gram
In Commercial Distribution

  • M724CSG141 ()
  • M724CSG1412PK2 ()
CSG-14

  • Scar-management dressing, reusable
Scar and Laser Gel
IMPLANTECH ASSOCIATES, INC.
5 gram
In Commercial Distribution

  • M724CSG051 ()
  • M724CSG0512PK2 ()
CSG-05

  • Scar-management dressing, reusable
WeL® Retractor-Nosed Tip
IMPLANTECH ASSOCIATES, INC.
5092, Sterile
In Commercial Distribution

  • M7245092ST1 ()
  • M7245092ST2 ()
5092-ST

  • Suction system catheter, general-purpose
WeL® Bullet-Nosed Tip
IMPLANTECH ASSOCIATES, INC.
5091, Sterile
In Commercial Distribution

  • M7245091ST1 ()
  • M7245091ST2 ()
5091-ST

  • Suction system catheter, general-purpose
Silicone Sheeting Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 1.016mm
In Commercial Distribution

  • M72423701402 ()
  • M72423701401 ()
23-701-40

  • Silicone-sheet tissue reconstructive material, non-sterile
Silicone Sheeting Reinforced
IMPLANTECH ASSOCIATES, INC.
Size: 50.8mm x 76.2mm x 0.381mm
In Commercial Distribution

  • M72423701152 ()
  • M72423701151 ()
23-701-15

  • Silicone-sheet tissue reconstructive material, non-sterile
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