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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*VRA1001T2
In Commercial Distribution

  • 34987350706691 ()
  • 04987350706690 ()


  • Cardiotomy reservoir
No Description
TERUMO CORPORATION
CX*VRA0701T2
In Commercial Distribution

  • 34987350706592 ()
  • 04987350706591 ()


  • Cardiotomy reservoir
No Description
TERUMO CORPORATION
CX*VRA0401T2
In Commercial Distribution

  • 34987350706493 ()
  • 04987350706492 ()


  • Cardiotomy reservoir
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
No Description
TERUMO CORPORATION
CX*AF125X
In Commercial Distribution

  • 54987350763353 ()
  • 04987350763358 ()


  • 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
Pall LeukoGuard BC2 Blood Cardioplegia Filter
Pall International Sàrl
BC2B
In Commercial Distribution

  • 35034480306105 ()
  • 05034480306104 ()

  • Reduce the level of leucocytes and exclude microemboli greater than 40 µm in size
  • Pore Size: 40 Micrometer
BC2B

  • Cardiopulmonary bypass system filter, blood/cardioplegia solution
Pall LeukoGuard LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop
Global Life Sciences Solutions USA LLC
LGB
Not in Commercial Distribution

  • 35034480004056 ()
  • 05034480004055 ()

  • Pore Size: 40 Micrometer
  • Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
LGB

  • Cardiopulmonary bypass system filter, arterial blood line
Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service (with Bypass Loop)
Pall International Sàrl
LG6B
In Commercial Distribution

  • 35034480000409 ()
  • 05034480000408 ()

  • Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
  • Pore Size: 40 Micrometer
LG6B

  • Cardiopulmonary bypass system filter, arterial blood line
Pall LeukoGuard LG Leukocyte Reduction Arterial Blood Filter for Extracorporeal Service
Pall International Sàrl
LG6
In Commercial Distribution

  • 35034480000393 ()
  • 05034480000392 ()

  • Pore Size: 40 Micrometer
  • Reduce the levels of circulating leucocytes and exclude microemboli greater than 40 µm in size
LG6

  • Cardiopulmonary bypass system filter, arterial blood line
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
Atlas SSLR Buttress Assembly
STANDARD BARIATRICS, INC
IPN928199
In Commercial Distribution

  • 00851677007140 ()
  • 20851677007144 ()
SSLR23

  • Staple line-reinforcement strip
FILTER 351T TRILL AFFINITY
MEDTRONIC, INC.
351T
Not in Commercial Distribution

  • 20721902363591 ()
  • 00721902363597 ()

  • Pore Size: 38.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line
ARTERIAL FILTER BB4014PEDS BB STERILE
MEDTRONIC, INC.
BB4014
In Commercial Distribution

  • 20643169878123 ()
  • 00643169878129 ()


  • Cardiopulmonary bypass system filter, arterial blood line
FILTER CB851 AF100 WITH CORTIVA 26L
MEDTRONIC, INC.
CB851
In Commercial Distribution

  • 20643169878116 ()
  • 00643169878112 ()


  • Cardiopulmonary bypass system filter, arterial blood line
FILTER S4014 AFFINITYPEDIATRIC ART ST
MEDTRONIC, INC.
S4014
In Commercial Distribution

  • 20643169858910 ()
  • 00643169858916 ()


  • Cardiopulmonary bypass system filter, arterial blood line
FILTER 61399409434 AFFINITY 6PK ARFIL20M
MEDTRONIC, INC.
61399409434
In Commercial Distribution

  • 20643169858842 ()
  • 00643169858848 ()

  • Pore Size: 20.0 Micrometer


  • Cardiopulmonary bypass system filter, arterial blood line
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