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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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AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 2 R/O Markers
ANGIODYNAMICS, INC.
13709304
In Commercial Distribution

  • H787137093045 ()
  • H787137093040 ()
  • 15051684005869 ()

  • Outer Diameter: 1.4 Millimeter
  • Catheter Gauge: 4 French
  • Pressure: 1050 Pound per Square Inch
  • Length: 90 Centimeter


  • Angiographic catheter, single-use
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 2 R/O Markers
ANGIODYNAMICS, INC.
13709302
In Commercial Distribution

  • H787137093025 ()
  • H787137093020 ()
  • 15051684005845 ()

  • Pressure: 1050 Pound per Square Inch
  • Outer Diameter: 1.8 Millimeter
  • Catheter Gauge: 5 French
  • Length: 90 Centimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
ANGIODYNAMICS, INC.
10732302
In Commercial Distribution

  • H787107323025 ()
  • H787107323020 ()
  • 15051684009737 ()

  • Pressure: 1050 Pound per Square Inch
  • Length: 90 Centimeter
  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
ANGIODYNAMICS, INC.
10732204
In Commercial Distribution

  • H787107322045 ()
  • H787107322040 ()
  • 15051684009706 ()

  • Pressure: 1050 Pound per Square Inch
  • Catheter Gauge: 5 French
  • Length: 90 Centimeter
  • Outer Diameter: 1.8 Millimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
ANGIODYNAMICS, INC.
10732202
In Commercial Distribution

  • H787107322025 ()
  • H787107322020 ()
  • 15051684009683 ()

  • Length: 90 Centimeter
  • Pressure: 1050 Pound per Square Inch
  • Catheter Gauge: 5 French
  • Outer Diameter: 1.8 Millimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Straight Flush, Non-Braided
ANGIODYNAMICS, INC.
10708604
In Commercial Distribution

  • H787107086045 ()
  • H787107086040 ()
  • 15051684006644 ()

  • Pressure: 1050 Pound per Square Inch
  • Catheter Gauge: 5 French
  • Length: 90 Centimeter
  • Outer Diameter: 1.8 Millimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Straight Flush, Non-Braided
ANGIODYNAMICS, INC.
10708602
In Commercial Distribution

  • H787107086025 ()
  • H787107086020 ()
  • 15051684006620 ()

  • Length: 90 Centimeter
  • Catheter Gauge: 5 French
  • Pressure: 1050 Pound per Square Inch
  • Outer Diameter: 1.8 Millimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
ANGIODYNAMICS, INC.
10708505
In Commercial Distribution

  • H787107085055 ()
  • H787107085050 ()
  • 15051684006583 ()

  • Outer Diameter: 1.8 Millimeter
  • Length: 90 Centimeter
  • Pressure: 1050 Pound per Square Inch
  • Catheter Gauge: 5 French


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Halo, Non-Braided
ANGIODYNAMICS, INC.
10708202
Not in Commercial Distribution

  • H787107082025 ()
  • H787107082020 ()
  • 15051684006477 ()

  • Outer Diameter: 1.4 Millimeter
  • Catheter Gauge: 4 French
  • Length: 90 Centimeter
  • Pressure: 1050 Pound per Square Inch


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
ANGIODYNAMICS, INC.
10707102
In Commercial Distribution

  • H787107071025 ()
  • H787107071020 ()
  • 15051684006163 ()

  • Outer Diameter: 1.4 Millimeter
  • Pressure: 1050 Pound per Square Inch
  • Catheter Gauge: 4 French
  • Length: 90 Centimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Straight Flush, Non-Braided
ANGIODYNAMICS, INC.
10714006
In Commercial Distribution

  • H787107140065 ()
  • H787107140060 ()
  • 15051684007825 ()

  • Length: 90 Centimeter
  • Pressure: 1050 Pound per Square Inch
  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided
ANGIODYNAMICS, INC.
10714005
In Commercial Distribution

  • H787107140055 ()
  • H787107140050 ()
  • 15051684007818 ()

  • Catheter Gauge: 4 French
  • Outer Diameter: 1.4 Millimeter
  • Length: 90 Centimeter
  • Pressure: 1050 Pound per Square Inch


  • Angiographic catheter, single-use
Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided
ANGIODYNAMICS, INC.
10714004
In Commercial Distribution

  • H787107140045 ()
  • H787107140040 ()
  • 15051684007801 ()

  • Length: 90 Centimeter
  • Catheter Gauge: 4 French
  • Pressure: 1050 Pound per Square Inch
  • Outer Diameter: 1.4 Millimeter


  • Angiographic catheter, single-use
50 PSI PRST OXY REG CGA 540 IN CO CH OUT
OHIO MEDICAL, LLC
GR-540-CF
In Commercial Distribution

  • 00628101621636 ()
GR-540-CF

  • Non-fixed medical gas cylinder regulator
50 PSI PRST REG CGA 346 AIR IN CO CH OUT
OHIO MEDICAL, LLC
GR-346-CF
In Commercial Distribution

  • 00628101621605 ()
GR-346-CF

  • Non-fixed medical gas cylinder regulator
LP35,EN-US,MAS-SP/CO/MET,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/C
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873772652 ()
99335-000013

  • Physiologic-monitoring defibrillation system
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,12L,WIFI/CELL/LN/CPRIN
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873765609 ()
99335-000031

  • Physiologic-monitoring defibrillation system
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 80mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3580
In Commercial Distribution

  • M711050021335800 ()

  • Length: 80 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 70mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3570
In Commercial Distribution

  • M711050021335700 ()

  • Length: 70 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 60mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3560
In Commercial Distribution

  • M711050021335600 ()

  • Length: 60 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 50mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3550
In Commercial Distribution

  • M711050021335500 ()

  • Length: 50 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 40mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3540
In Commercial Distribution

  • M711050021335400 ()

  • Length: 40 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
Posterior Cervical, Rod, Prebent, CoCr, 3.5mm x 30mm, Co 28Cr 6Mo
Innovasis, Inc.
05-002-13-3530
In Commercial Distribution

  • M711050021335300 ()

  • Length: 30 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X 360, Co 28Cr 6Mo
Innovasis, Inc.
05-002-10-3536
In Commercial Distribution

  • M711050021035360 ()

  • Length: 360 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X 240, Co 28Cr 6Mo
Innovasis, Inc.
05-002-10-3524
In Commercial Distribution

  • M711050021035240 ()

  • Length: 240 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X 120, Co 28Cr 6Mo
Innovasis, Inc.
05-002-10-3512
In Commercial Distribution

  • M711050021035120 ()

  • Length: 120 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
POSTERIOR CERVICAL, ROD, STRAIGHT, CoCr, 3.5 X 80, Co 28Cr 6Mo
Innovasis, Inc.
05-002-10-3508
In Commercial Distribution

  • M711050021035080 ()

  • Length: 80 Millimeter
  • Outer Diameter: 3.5 Millimeter


  • Bone-screw internal spinal fixation system rod
A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
Not in Commercial Distribution

  • 72900130302906 ()
CMMST5S

  • Multiple vital physiological parameter monitoring system, clinical
Adult Nasal/Oral Dual CO2 Sampling Cannula w/O2 Delivery, CO
TRINITY MEDICAL DEVICES INC.
TOT807
In Commercial Distribution

  • 00813880025939 ()
  • 00813880025823 ()


  • Nasal oxygen cannula, carbon-dioxide-sampling
GAS DLCO (RTD) 0.3%CO, 0.3%CH4, 21%O2, BAL N2
MEDICAL GRAPHICS CORPORATION
536057-001
In Commercial Distribution

  • 00810016251552 ()
536057-001

  • Pulmonary function analysis system, adult
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