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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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(C3.4) Ø3.5/ L8.5
Megagen Implant Co. Ltd
EF3508
In Commercial Distribution

  • 08806388213047 ()
EF3508P

  • Screw endosteal dental implant, two-piece
(C3.4) Ø3.5/ L7.0
Megagen Implant Co. Ltd
EF3507
In Commercial Distribution

  • 08806388213023 ()
EF3507P

  • Screw endosteal dental implant, two-piece
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
6 Drainable Collection Bags, 500 ml, with female Luer-lock connector, a suspension hook, and a hydrophobic filter.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910116D
Not in Commercial Distribution

  • 30381780035552 ()
  • 10381780035558 ()
  • M272910116D1 ()

  • Drainage Bag 500ml, Hydrophobic Filter 0.45µm
910116D

  • Cerebrospinal fluid external drainage kit
Replacement Drainage Bag, 500 ml, with female Luer-lock connector, a suspension hook, and a hydrophobic filter.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
910116A
Not in Commercial Distribution

  • 30381780035545 ()
  • 10381780035541 ()
  • M272910116A1 ()

  • Drainage Bag 500ml, Hydrophobic Filter 0.45µm
910116A

  • 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. 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 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
UE XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169719 ()
99-91647UE

  • External orthopaedic fixation system, single-use
JP XCALIBER ANKLE COMPLETE KIT
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032937169702 ()
99-91647JP

  • External orthopaedic fixation system, single-use, sterile
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