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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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PEDIASAT - 00690103197518

PEDIASAT OXIMETRY CATHETER SET
Edwards Lifesciences LLC
XT248SP
In Commercial Distribution

  • 00690103197518 ()

  • EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 8CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM)
XT248SP

  • Oximeter catheter, single-use

PEDIASAT - 00690103197488

PEDIASAT OXIMETRY CATHETER SET
Edwards Lifesciences LLC
XT245SP
In Commercial Distribution

  • 00690103197488 ()

  • EXTERIOR DIAMETER: 4.5F (1.50MM), USABLE LENGTH: 5CM, RECOMMENDED GUIDEWIRE SIZE: 0.018 IN (0.46 MM)
XT245SP

  • Oximeter catheter, single-use

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER - 00690103197457

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER KIT
Edwards Lifesciences LLC
X3820KT
In Commercial Distribution

  • 00690103197457 ()

  • EXTERIOR DIAMETER:8.5F (2.8MM), USABLE LENGTH:20 CM, MAXIMUM GUIDEWIRE SIZE: 0.032IN (0.81 MM)
X3820KT

  • Oximeter catheter, single-use

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER - 00690103197440

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER KIT
Edwards Lifesciences LLC
X3816KT
In Commercial Distribution

  • 00690103197440 ()

  • EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 16CM, RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81 MM)
X3816KT

  • Oximeter catheter, single-use

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER - 00690103197433

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Edwards Lifesciences LLC
X3820SP
In Commercial Distribution

  • 00690103197433 ()

  • EXTERIOR DIAMETER: 8.5F (2.8MM), USABLE LENGTH: 20CM, RECOMMENDED GUIDEWIRE SIZE: 0.032 IN (0.81 MM)
X3820SP

  • Oximeter catheter, single-use

NA - 08717213050020

seedSelectron Treatment Needles, Sterile
Nucletron B.V.
130334-00
Not in Commercial Distribution

  • 08717213050020 ()


  • Remote-afterloading brachytherapy system

NA - 08717213043794

seedSelectron Treatment Accessories, Sterile (RNA)/ Pre-Plugged
Nucletron B.V.
130038-05
In Commercial Distribution

  • 08717213043794 ()


  • Remote-afterloading brachytherapy system

selectSpacer - 08717213050013

seedSelectron Treatment Needles, Sterile / Pre-Plugged
Nucletron B.V.
130335-00
In Commercial Distribution

  • 08717213050013 ()


  • Remote-afterloading brachytherapy system

NA - 08717213028654

Prostate Stabilization Needle Set
Nucletron B.V.
130045-01
Not in Commercial Distribution

  • 08717213036918 ()
  • 08717213028654 ()
  • 08717213028661 ()


  • Remote-afterloading brachytherapy system

NA - 08717213028647

Obturator 1 X 225 Sterile
Nucletron B.V.
130042-00
Not in Commercial Distribution

  • 08717213028647 ()


  • Remote-afterloading brachytherapy system
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