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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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This is a kit containing a medical device.
Dental Imaging Technologies Corporation
1.013.2914
In Commercial Distribution

10132914

  • Dental digital imaging sensor, intraoral
This is a kit containing a medical device.
Dental Imaging Technologies Corporation
1.013.2914
Not in Commercial Distribution

  • EKAV101329140 ()
10132914

  • Dental digital imaging sensor, intraoral
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
Radixact Delivery System Software (Version 1.1)
ACCURAY INCORPORATED
1060253
In Commercial Distribution

  • M65810602530 ()
N/A

  • Linear accelerator system
Software, TomoApps, Version 2.1.1, Build # 5.1.1 (Operating Software for TomoTherapy systems, including TomoH®, TomoHD®, TomoHDA™ and Onrad™)
ACCURAY INCORPORATED
1048968
In Commercial Distribution

  • M65810489680 ()
N/A

  • Linear accelerator system
STYLET ONLY F/BRUENING NASAL SNARE
JEDMED INSTRUMENT COMPANY
51-2384 A
In Commercial Distribution

  • M633512384A0 ()
51-2384 A

  • Nasal snare, reusable
ENT Endoscope 2.7MM 30-Deg 175MM
JEDMED INSTRUMENT COMPANY
49-4313 A
In Commercial Distribution

  • M633494313A0 ()
49-4313 A

  • Rigid optical sinoscope
ENT Endoscope 4MM 30-Deg 175MM
JEDMED INSTRUMENT COMPANY
49-4303 A
In Commercial Distribution

  • M633494303A0 ()
49-4303 A

  • Rigid optical sinoscope
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