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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NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive
In Commercial Distribution

  • 27290016450044 ()
NNW-006010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Libenger RM frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954094 ()
700-020874-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
No Description
Bird & Cronin, LLC
08146545
In Commercial Distribution

  • 50610570149945 ()
  • 00610570149940 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140780
In Commercial Distribution

  • 50610570004046 ()
  • 00610570004041 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140680
In Commercial Distribution

  • 50610570003612 ()
  • 00610570003617 ()


  • Gait rehabilitation system harness
No Description
Ad-Tech Medical Instrument Corporation
11
In Commercial Distribution

  • 00841823109729 ()
BF08R-SP05X-0BH

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
8
In Commercial Distribution

  • 00841823109699 ()
BF09R-SP05X-0BE

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
7
In Commercial Distribution

  • 00841823109682 ()
BF09R-SP21X-0CC

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
6
In Commercial Distribution

  • 00841823109675 ()
BF09R-SP61X-0CC

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
4
In Commercial Distribution

  • 00841823109651 ()
BF10R-SP21X-0C3

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
3
In Commercial Distribution

  • 00841823109644 ()
BF10R-SP61X-0C3

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
2
In Commercial Distribution

  • 00841823109637 ()
BF12R-SP05X-0BH

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
1
In Commercial Distribution

  • 00841823109620 ()
BF12R-SP21X-0C3

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
0
In Commercial Distribution

  • 00841823109613 ()
BF12R-SP61X-0C3

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM31A-SP53X-000
In Commercial Distribution

  • 00841823109576 ()
MM31A-SP53X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM29A-SP52X-000
In Commercial Distribution

  • 00841823109569 ()
MM29A-SP52X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
MM32D-SP05X-000
In Commercial Distribution

  • 00841823109552 ()
MM32D-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD07R-SP45X-0T0
In Commercial Distribution

  • 00841823109514 ()
SD07R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP45X-000
In Commercial Distribution

  • 00841823109507 ()
SD06R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD16R-SP05X-000
In Commercial Distribution

  • 00841823109491 ()
SD16R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP45X-0T1
In Commercial Distribution

  • 00841823109484 ()
SD14R-SP45X-0T1

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP05X-000
In Commercial Distribution

  • 00841823109477 ()
SD14R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP03X-000
In Commercial Distribution

  • 00841823109460 ()
SD14R-SP03X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD13R-SP45X-0T2
In Commercial Distribution

  • 00841823109453 ()
SD13R-SP45X-0T2

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP45X-000
In Commercial Distribution

  • 00841823109446 ()
SD12R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP10X-000
In Commercial Distribution

  • 00841823109439 ()
SD12R-SP10X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP05X-000
In Commercial Distribution

  • 00841823109286 ()
SD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP08X-000
In Commercial Distribution

  • 00841823109231 ()
SD06R-SP08X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP05X-000
In Commercial Distribution

  • 00841823109217 ()
SD06R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD05R-SP45X-0T0
In Commercial Distribution

  • 00841823109187 ()
SD05R-SP45X-0T0

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD04R-SP45X-000
In Commercial Distribution

  • 00841823109163 ()
SD04R-SP45X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD04R-SP05X-000
In Commercial Distribution

  • 00841823109132 ()
SD04R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD044-SP07X-A00
In Commercial Distribution

  • 00841823109071 ()
SD044-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
SD042-SP07X-A00
In Commercial Distribution

  • 00841823109057 ()
SD042-SP07X-A00

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD08R-SP05X-000
In Commercial Distribution

  • 00841823108890 ()
RD08R-SP05X-000

  • Depth electrode
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