Company Name Brand Name GMDN Term 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
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954974 ()
  • 07290014954977 ()
STR-94685Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954967 ()
  • 07290014954960 ()
STR-94685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954950 ()
  • 07290014954953 ()
STR-000664-21

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954943 ()
  • 07290014954946 ()
STR-AP9080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954868 ()
  • 07290014954861 ()
STR-000136-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954847 ()
  • 17290014954844 ()
STR-001080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954830 ()
  • 17290014954837 ()
STR-000081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954625 ()
  • 17290014954622 ()
STR-901079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954618 ()
  • 17290014954615 ()
STR-901024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954601 ()
  • 17290014954608 ()
STR-009024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290014954595 ()
  • 17290014954592 ()
STR-009079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954588 ()
  • 17290014954585 ()
STR-090244-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954571 ()
  • 17290014954578 ()
STR-922780-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954564 ()
  • 17290014954561 ()
STR-921480-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954557 ()
  • 17290014954554 ()
STR-901080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954540 ()
  • 17290014954547 ()
STR-009081-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954533 ()
  • 17290014954530 ()
STR-009023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Shielded
In Commercial Distribution

  • 07290014954526 ()
  • 17290014954523 ()
STR-009080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954519 ()
  • 17290014954516 ()
STR-22675L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954502 ()
  • 17290014954509 ()
17290014954509

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954496 ()
  • 17290014954493 ()
STR-34685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954489 ()
  • 17290014954486 ()
STR-34685Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954472 ()
  • 17290014954479 ()
STR-000925-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954465 ()
  • 17290014954462 ()
17290014954462

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954458 ()
  • 17290014954455 ()
STR-000425-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954441 ()
  • 17290014954448 ()
STR-000025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954434 ()
  • 17290014954431 ()
STR-001124-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954427 ()
  • 17290014954424 ()
STR-001024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954410 ()
  • 17290014954417 ()
STR-000024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954403 ()
  • 17290014954400 ()
STR-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954397 ()
  • 17290014954394 ()
STR-107079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954380 ()
  • 17290014954387 ()
STR-001079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954373 ()
  • 17290014954370 ()
STR-000079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954359 ()
  • 17290014954356 ()
STR-022780-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954342 ()
  • 17290014954349 ()
STR-021480-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954335 ()
  • 17290014954332 ()
STR-007080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954328 ()
  • 17290014954325 ()
STR-000426-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 07290014954311 ()
  • 17290014954318 ()
STR-000080-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290014954073 ()
  • 07290014954076 ()
STR-222291-00

  • Depth electrode
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
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
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
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
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.
440575
In Commercial Distribution

  • 04035479160517 ()
  • 04035479160630 ()


  • Cardiovascular patch, animal-derived
Smoke Attachment
Covidien LP
E3590
In Commercial Distribution

  • 20884524000296 ()
  • 10884524000299 ()
E3590

  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000725
In Commercial Distribution

  • 50749756314768 ()
  • 00749756314763 ()


  • Surgical plume evacuation system
Smoke EVAC Wand
DEROYAL INDUSTRIES, INC.
88-000700
In Commercial Distribution

  • 50749756305650 ()
  • 00749756305655 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-015722
In Commercial Distribution

  • 50749756248117 ()
  • 00749756248112 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000703
In Commercial Distribution

  • 50749756237487 ()
  • 00749756237482 ()


  • Surgical plume evacuation system
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