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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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Autoclavable Drive - 07290114060899

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 4
In Commercial Distribution

  • 07290114060899 ()
750-000027-00

  • Depth electrode

Neuro Omega Autoclavable Drive Headstage - 07290114060882

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 6.0
In Commercial Distribution

  • 07290114060882 ()
750-000025-00

  • Depth electrode

Power cable - 07290114060875

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-5.5mm
In Commercial Distribution

  • 07290114060875 ()
190-000117-11

  • Depth electrode

Power cable - 07290114060851

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type N-4 mm
In Commercial Distribution

  • 07290114060851 ()
190-000117-15

  • Depth electrode

Power cable - 07290114060844

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type K
In Commercial Distribution

  • 07290114060844 ()
190-000117-14

  • Depth electrode

Power cable - 07290114060820

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type D
In Commercial Distribution

  • 07290114060820 ()
190-000117-12

  • Depth electrode

NeuroSmart NeuroForits Drive Headstage - 07290114060790

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart NeuroForits Drive Headstage
In Commercial Distribution

  • 07290114060790 ()


  • Depth electrode

Neuro Omega NeuroFortis Drive Headstage - 07290114060561

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega NeuroFortis Drive Headstage
In Commercial Distribution

  • 07290114060561 ()
750-000070-00

  • Depth electrode

Power cable - 07290114060554

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type H
In Commercial Distribution

  • 07290114060554 ()
190-000117-09

  • Depth electrode

Power cable - 07290114060547

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type F
In Commercial Distribution

  • 07290114060547 ()
190-000117-08

  • Depth electrode

Power cable - 07290114060530

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type I
In Commercial Distribution

  • 07290114060530 ()
190-000117-07

  • Depth electrode

Power cable - 07290114060523

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type M
In Commercial Distribution

  • 07290114060523 ()
190-000117-05

  • Depth electrode

Power cable - 07290114060516

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-4mm
In Commercial Distribution

  • 07290114060516 ()
190-000117-04

  • Depth electrode

Power cable - 07290114060509

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type J
In Commercial Distribution

  • 07290114060509 ()
190-000117-03

  • Depth electrode

Power cable - 07290114060493

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type G
In Commercial Distribution

  • 07290114060493 ()
190-000117-02

  • Depth electrode

Power cable - 07290114060486

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type B
In Commercial Distribution

  • 07290114060486 ()
190-000117-01

  • Depth electrode

Biotronik BioEnvelope - 04035479160555

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440579
In Commercial Distribution

  • 04035479160647 ()
  • 04035479160555 ()

  • SubQ


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160548

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440578
In Commercial Distribution

  • 04035479160548 ()
  • 04035479160654 ()

  • Width: 9.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160531

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440577
In Commercial Distribution

  • 04035479160531 ()
  • 04035479160616 ()

  • Width: 8.0 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived

Biotronik BioEnvelope - 04035479160524

The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable devices that may be used with the BioEnvelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
AZIYO BIOLOGICS, INC.
440576
In Commercial Distribution

  • 04035479160524 ()
  • 04035479160623 ()

  • Width: 6.5 Centimeter
  • Height: 6.9 Centimeter


  • Cardiovascular patch, animal-derived
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