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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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Medex - 10351688510624

No Description
ICU MEDICAL, INC.
M20858R1
In Commercial Distribution

  • 50351688510622 ()
  • 10351688510624 ()


  • Pressure transducer dome, single-use

Medex - 10351688510617

No Description
ICU MEDICAL, INC.
M20869R2
In Commercial Distribution

  • 50351688510615 ()
  • 10351688510617 ()


  • Pressure transducer dome, single-use

MICRO - 08033178114608

No Description
SORIN GROUP ITALIA SRL
40 µm Infant Arterial Filter
In Commercial Distribution

  • 38033178114609 ()
  • 08033178114608 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178114578

No Description
SORIN GROUP ITALIA SRL
40 µm Adult Arterial Filter
In Commercial Distribution

  • 38033178114579 ()
  • 08033178114578 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178114561

No Description
SORIN GROUP ITALIA SRL
40 µm Small Adult Arterial Filter
In Commercial Distribution

  • 38033178114562 ()
  • 08033178114561 ()


  • Cardiopulmonary bypass system filter, arterial blood line

KIDS - 08033178109314

No Description
SORIN GROUP ITALIA SRL
D131 INFANT ART. FILTER PH + PURGE LINE
In Commercial Distribution

  • 38033178109315 ()
  • 08033178109314 ()


  • Cardiopulmonary bypass system filter, arterial blood line

KIDS - 08033178109154

No Description
SORIN GROUP ITALIA SRL
D130 NEONATAL ART.FILTER PH+PURGE LINE
In Commercial Distribution

  • 38033178109155 ()
  • 08033178109154 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100892

No Description
SORIN GROUP ITALIA SRL
D736 40µ NEW BORN ART.FILTER+PURGE LINE
In Commercial Distribution

  • 38033178100893 ()
  • 08033178100892 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100885

No Description
SORIN GROUP ITALIA SRL
D735 27µ NEW BORN ART.FILTER+PURGE LINE
In Commercial Distribution

  • 38033178100886 ()
  • 08033178100885 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100847

No Description
SORIN GROUP ITALIA SRL
D734 40µ AD ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100848 ()
  • 08033178100847 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100830

No Description
SORIN GROUP ITALIA SRL
D732 27µ AD ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100831 ()
  • 08033178100830 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100823

No Description
SORIN GROUP ITALIA SRL
D733 40µ PED ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100824 ()
  • 08033178100823 ()


  • Cardiopulmonary bypass system filter, arterial blood line

MICRO - 08033178100816

No Description
SORIN GROUP ITALIA SRL
D731 27µ PED ART. FILTER + PURGE LINE
In Commercial Distribution

  • 38033178100817 ()
  • 08033178100816 ()


  • Cardiopulmonary bypass system filter, arterial blood line

ECHLEON - 10705036023296

ECHELON 60MM REINFORCEMENT
ETHICON ENDO-SURGERY, LLC
ECH60R
In Commercial Distribution

  • 20705036023293 ()
  • 10705036023296 ()
  • 30705036023290 ()
ECH60R

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

Biodesign - 00827002542525

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G54252
Not in Commercial Distribution

  • 00827002542525 ()
C-SLRA-OPEN-GIA80

  • Staple line-reinforcement strip

Biodesign - 00827002542518

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G54251
Not in Commercial Distribution

  • 00827002542518 ()
C-SLRA-OPEN-GIA60

  • Staple line-reinforcement strip

Biodesign - 00827002508712

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50871
Not in Commercial Distribution

  • 00827002508712 ()
C-SLRA-ECH60

  • Staple line-reinforcement strip

Biodesign - 00827002508705

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50870
Not in Commercial Distribution

  • 00827002508705 ()
C-SLRA-EZ45

  • Staple line-reinforcement strip

Biodesign - 00827002508682

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50868
Not in Commercial Distribution

  • 00827002508682 ()
C-SLRA-GIA45

  • Staple line-reinforcement strip

Biodesign - 00827002508675

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50867
Not in Commercial Distribution

  • 00827002508675 ()
C-SLRA-GIA60

  • Staple line-reinforcement strip

Biodesign - 00827002508668

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50866
Not in Commercial Distribution

  • 00827002508668 ()
C-SLRA-TCT-TLC55

  • Staple line-reinforcement strip

Biodesign - 00827002508651

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50865
Not in Commercial Distribution

  • 00827002508651 ()
C-SLRA-TCT-TLC75

  • Staple line-reinforcement strip

Biodesign - 00827002517462

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G51746
Not in Commercial Distribution

  • 00827002517462 ()
C-SLRA-ECH45

  • Staple line-reinforcement strip

Biodesign - 00827002506565

Biodesign Staple Line Reinforcement
COOK BIOTECH INCORPORATED
G50656
Not in Commercial Distribution

  • 00827002506565 ()
C-SLRA-GIA30

  • Staple line-reinforcement strip

Affinity® - 00613994404893

FILTER CB4014 AFF PED ART CC ST CEM 4PK
MEDTRONIC, INC.
CB4014
Not in Commercial Distribution

  • 20613994404897 ()
  • 00613994404893 ()


  • Cardiopulmonary bypass system filter, arterial blood line

NEOVEIL - 04547301462558

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-M60E-2
In Commercial Distribution

  • 04547301462558 ()

  • Length: 60 Millimeter
  • Width: 18 Millimeter
NV-ET-M60E-2

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

NEOVEIL - 04547301462534

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-M60A-2
In Commercial Distribution

  • 04547301462534 ()

  • Length: 60 Millimeter
  • Width: 17 Millimeter
NV-ET-M60A-2

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

MedStream - 00842472100372

FILTER-PEDIATRIC .22 MCRN
MEDICAL SPECIALTIES DISTRIBUTORS, LLC
MS428
In Commercial Distribution

  • 10842472100379 ()
  • 00842472100372 ()
MS428

  • Intravenous administration tubing extension set

QUART - 04037691253862

The QUART arterial filter (HBF 140) with SOFTLINE coating, sterile, is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.
Maquet Cardiopulmonary AG
BO-HBF 140, SOFTLINE, Sterile
Not in Commercial Distribution

  • 04037691117911 ()
  • 04037691253862 ()

  • Area/Surface Area: 570 Square centimeter
  • maximum blood flow [l/min] 7 0
  • connection size inlet 3/8 Inch
  • connection size outlet 3/8 Inch
  • priming volume 180 Milliliter
  • Pore Size: 40 Micrometer
70103.2033

  • Blood transfusion filter

QUART - 04037691173412

QUART Arterial Filter with BIOLINE Coating, Sterile. The QUART arterial filter (HBF 140) is a screen filter with integrated bypass and pre-postdeairing mechanic. It is used for removing gaseous embolisms and aggregates from blood components of the arterial bloodline during extracorporeal circulation. Therefore utilization of the arterial filter reduces the patient’s risk of injury from a micro embolism caused by gases or solids.
Maquet Cardiopulmonary AG
BEQ-HBF 140 Arterial Filter, Sterile
Not in Commercial Distribution

  • 04037691173412 ()
  • 04037691173405 ()

  • Area/Surface Area: 570 Square centimeter
  • maximum blood flow [l/min] 7 0
  • connection size inlet 3/8 Inch
  • connection size outlet 3/8 Inch
  • priming volume 180 Milliliter
  • Pore Size: 40 Micrometer
70101.2811

  • Blood transfusion filter
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