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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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No Description
BIOTRONIK SE & Co. KG
377206
Not in Commercial Distribution

  • 04035479118358 ()
377206

  • Cardiac resynchronization therapy implantable pacemaker
No Description
BIOTRONIK SE & Co. KG
OTW-L 75-BP
In Commercial Distribution

  • 04035479112165 ()

  • Max. Diameter: 1.95 mm
  • Length: 77 cm
368345

  • Coronary venous pacing lead
No Description
BIOTRONIK SE & Co. KG
OTW-S 75-BP
In Commercial Distribution

  • 04035479094157 ()

  • Length: 77 cm
  • Max. Diameter: 1.95 mm
355148

  • Coronary venous pacing lead
No Description
BIOTRONIK SE & Co. KG
OTW 75-BP
In Commercial Distribution

  • 04035479093532 ()

  • Length: 77 cm
  • Max. Diameter: 1.95 mm
354805

  • Coronary venous pacing lead
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 3-piece plate is made from PEEK.
Neurovention LLC
410-01
In Commercial Distribution

  • G28441001 ()


  • Cranioplasty plate, alterable
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 2-piece plate is made from PEEK .
Neurovention LLC
409-01
In Commercial Distribution

  • G28440901 ()


  • Cranioplasty plate, alterable
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
Neurovention LLC
361-02
In Commercial Distribution

  • G28436102 ()


  • Cranioplasty plate, alterable
The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.
Neurovention LLC
330-01
In Commercial Distribution

  • G28433001 ()


  • Cranioplasty plate, alterable
No Description
Intelivation, LLC
HMR-4565D
In Commercial Distribution

  • G079HMR4565D0 ()


  • Phalangeal joint arthrodesis implant
Counter Rotation Ring, Large
Intelivation, LLC
HMR-4565
In Commercial Distribution

  • G079HMR45650 ()


  • Phalangeal joint arthrodesis implant
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