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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Stroke Application and Programming Software
Microtransponder
4001
In Commercial Distribution

  • 10810041430004 ()


  • Vagus nerve electrical stimulation system programmer
SEDASYS POWER SUPPLY UNIT
ETHICON ENDO-SURGERY, INC.
SEDPSU01
Not in Commercial Distribution

  • 10705036010210 ()
SEDPSU01

  • Intraprocedural physiologic-monitoring sedation system
SEDASYS CONTROL UNIT
ETHICON ENDO-SURGERY, INC.
SEDPRU01
Not in Commercial Distribution

  • 10705036010203 ()
SEDPRU01

  • Intraprocedural physiologic-monitoring sedation system
SEDASYS BEDSIDE MONITORING UNIT
ETHICON ENDO-SURGERY, INC.
SEDBMU01
Not in Commercial Distribution

  • 10705036010180 ()
SEDBMU01

  • Intraprocedural physiologic-monitoring sedation system
No Description
BIOTRONIK SE & Co. KG
438613
In Commercial Distribution

  • 04035479159115 ()
438613

  • Cardiac pulse generator reader, home-use
No Description
BIOTRONIK SE & Co. KG
399730
Not in Commercial Distribution

  • 04035479136642 ()
399730

  • Cardiac pulse generator reader, home-use
No Description
BIOTRONIK SE & Co. KG
399729
Not in Commercial Distribution

  • 04035479136635 ()
399729

  • Cardiac pulse generator reader, home-use
No Description
BIOTRONIK SE & Co. KG
399726
Not in Commercial Distribution

  • 04035479136628 ()
399726

  • Cardiac pulse generator reader, home-use
No Description
BIOTRONIK SE & Co. KG
370329
Not in Commercial Distribution

  • 04035479113407 ()
370329

  • Cardiac pulse generator reader, home-use
No Description
BIOTRONIK SE & Co. KG
370328
Not in Commercial Distribution

  • 04035479113391 ()
370328

  • Cardiac pulse generator reader, home-use
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