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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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No Description
TERUMO CORPORATION
CX*VRA0101T2
In Commercial Distribution

  • 34987350706394 ()
  • 04987350706393 ()


  • Cardiotomy reservoir
No Description
TERUMO CORPORATION
CX*AF02
In Commercial Distribution

  • 54987350705636 ()
  • 04987350705631 ()


  • Cardiopulmonary bypass system filter, arterial blood line
As packaged, NEOVEIL is a suture- and staple-reinforcement product composed of 100% bioabsorbable polyglycolic acid (PGA). This nonwoven product is dyed with D&C Green No.6 in order to make it readily visible to the surgeon. Two forms of NEOVEIL are provided. The Tube type model constitutes of pre-formed porous bio-absorbable nonwoven sheets and is intended for staple-line reinforcement. The Tube type model is provided in the form of sleeves, one for the cartridge and one for the anvil on a corresponding stapler. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The Sheet type model is simply a porous fibrous bio-absorbable sheet which is intended for suture-line reinforcement. The thickness of the bioabsorbable NEOVEIL staple line reinforcement ranges from 0.1 mm to 0.85 mm. Mesh weave characteristics and pore size are not applicable since NEOVEIL is nonwoven material. Average basis weight of the NEOVEIL model ranges from 35 to 225 (g/m2).
GUNZE LIMITED
NV-ET-M60L-3
In Commercial Distribution

  • 04973077713783 ()

  • Length: 60 Millimeter
  • Width: 17 Millimeter
NV-ET-M60L-3

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid(PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.
GUNZE LIMITED
NV-ET-M60E-3
In Commercial Distribution

  • 04973077713776 ()

  • Length: 60 Millimeter
  • Width: 17 Millimeter
NV-ET-M60E-3

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
No Description
TERUMO CORPORATION
CX*AF125X
In Commercial Distribution

  • 54987350763353 ()
  • 04987350763358 ()


  • Cardiopulmonary bypass system filter, arterial blood line
FILTER 1338 PEDIATRIC ARTERIAL 8PK 8L
MEDTRONIC, INC.
1338
Not in Commercial Distribution

  • 20673978707352 ()
  • 00673978707358 ()


  • Cardiopulmonary bypass system filter, arterial blood line
Pump Tubing Set with 0.2 micron filter for WalkMed Infusion Pump, 170 cm
WALKMED TECHNOLOGIES, LLC
204383
In Commercial Distribution

  • 00859695006039 ()
  • 10859695006036 ()

  • Pore Size: 0.2 Micrometer
  • Length: 170 Centimeter
FPS-560

  • Electric infusion pump administration set, single-use
Pump Tubing Set with check valve and filter for WalkMed Infusion Pump, 102 cm
WALKMED TECHNOLOGIES, LLC
203728
In Commercial Distribution

  • 10859695006029 ()
  • 00859695006022 ()

  • Length: 102 Centimeter
  • Pore Size: 0.2 Micrometer
EFV-101B

  • Electric infusion pump administration set, single-use
No Description
Terumo Cardiovascular Systems Corporation
CX*AF200X
In Commercial Distribution

  • 50699753450382 ()
  • 00699753450387 ()


  • Cardiopulmonary bypass system filter, arterial blood line
No Description
Terumo Cardiovascular Systems Corporation
AL6X
In Commercial Distribution

  • 50699753450016 ()
  • 00699753450011 ()


  • Cardiopulmonary bypass system filter, arterial blood line
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