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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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ORTHROS DUAL THREAD Ø8.5 MIS Screw, 60mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8560
In Commercial Distribution

  • B030ORM185600 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø8.5 MIS Screw, 55mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-8555
In Commercial Distribution

  • B030ORM185550 ()
N/A

  • Spinal bone screw, non-bioabsorbable
ORTHROS DUAL THREAD Ø5.5 MIS Screw, 100mm
CAMBER SPINE TECHNOLOGIES, LLC
ORM-1-85100
In Commercial Distribution

  • B030ORM1851000 ()
N/A

  • Spinal bone screw, non-bioabsorbable
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910110A
Not in Commercial Distribution

  • 30381780023719 ()
  • 10381780023715 ()
  • M272910110A1 ()

  • Cylinder 75ml, Drainage Bag 500ml
910110A

  • Cerebrospinal fluid external drainage kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910109
Not in Commercial Distribution

  • M2729101091 ()
  • 10381780034117 ()

  • Cylinder 75ml, Drainage Bag 500ml


  • Cerebrospinal fluid external drainage kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. A Ventricular Catheter Accessory Kit (VCAK). A Pressure Transducer.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910123A
Not in Commercial Distribution

  • 10381780035589 ()
  • M272910123A1 ()

  • Cylinder 75ml, Drainage Bag 500ml, Vent. Cath. 35cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducers 22cm and 37cm Length
910123A

  • Ventricular cerebrospinal fluid drainage catheterization kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. A Lumbar Catheter Accessory Kit (LCAK).
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910120A
Not in Commercial Distribution

  • 10381780035565 ()
  • M272910120A1 ()

  • Cylinder 75ml, Drainage Bag 500ml , Lumbar Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 14G Tuohy Needle
910120A

  • Lumbar cerebrospinal fluid drainage catheterization kit
The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale. It also includes a Ventricular Catheter Accessory Kit.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910112A
Not in Commercial Distribution

  • 10381780035527 ()
  • M272910112A1 ()

  • Cylinder 75ml, Drainage Bag 500ml, Vent. Cath. 35cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Introducers 22cm and 37cm Length
910112A

  • Ventricular cerebrospinal fluid drainage catheterization kit
The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location.
MESA BIOTECH, INC.
1028
In Commercial Distribution

  • B54010280 ()
1028

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
TSC Uni-Planar Screw 7.0 x 35mm
Seaspine, Inc.
70-7035
Not in Commercial Distribution

  • M5567070351 ()
  • 10381780006046 ()

  • 7.0 x 35mm
70-7035

  • Multiple Rickettsia species (typhus group) immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
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