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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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The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.
Shockwave Medical, Inc.
825Dx
In Commercial Distribution

  • 00195451000355 ()
IVLGCCDX

  • Intravascular lithotripsy system generator
Liquid Embolic 105-7100-080 Onyx 34
Micro Therapeutics, Inc.
105-7100-080
In Commercial Distribution

  • 00836462005051 ()


  • Neurovascular embolization plug
Trial Simulator Pouch Kit
Greatbatch Ltd
4320-USA
In Commercial Distribution

  • 00821329580369 ()
4320

  • Neurosurgical procedure kit, non-medicated, single-use
Adhesive Patches Kit
Greatbatch Ltd
4240-USA
In Commercial Distribution

  • 00821329580352 ()
4240

  • Neurosurgical procedure kit, non-medicated, single-use
Adjustable Belt Kit
Greatbatch Ltd
4220-USA
In Commercial Distribution

  • 00821329580345 ()
4220

  • Neurosurgical procedure kit, non-medicated, single-use
Programmer Power Cord Kit
Greatbatch Ltd
4010-USA
In Commercial Distribution

  • 00821329580338 ()
4010

  • Neurosurgical procedure kit, non-medicated, single-use
RX ACCULINK™ Carotid Stent System 7-10 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011344-40
In Commercial Distribution

  • 08717648076398 ()
1011344-40

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 7-10 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011344-30
In Commercial Distribution

  • 08717648076381 ()
1011344-30

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6-8 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011343-40
In Commercial Distribution

  • 08717648076374 ()
1011343-40

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6-8 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011343-30
In Commercial Distribution

  • 08717648076367 ()
1011343-30

  • Bare-metal carotid artery stent
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