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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Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906750
In Commercial Distribution

  • 00814716020074 ()


  • Surgical plume evacuation system
Smoke Evacuation Tubing Support Stand
COASTAL LIFE TECHNOLOGIES, INC.
907001
In Commercial Distribution

  • 00814716020777 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906760
In Commercial Distribution

  • 00814716020067 ()


  • Surgical plume evacuation system
Smoke Evacuator
COASTAL LIFE TECHNOLOGIES, INC.
906500
In Commercial Distribution

  • 00814716020050 ()


  • Surgical plume evacuation system
No Description
Synapse Biomedical, Inc.
20-0070
In Commercial Distribution

  • 00852184003328 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
No Description
Jeil Medical Corporation
111-299
In Commercial Distribution

  • 08806390885331 ()


  • Bone graft packing block
No Description
Synapse Biomedical, Inc.
22-0028
In Commercial Distribution

  • 00852184003410 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC1016SN
In Commercial Distribution

  • 00085412530710 ()
PC1016SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0814SN
In Commercial Distribution

  • 00085412530697 ()
PC0814SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0608SN
In Commercial Distribution

  • 00085412530673 ()
PC0608SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD Repair Patch is prepared from bovine pericardium cross-linked with glutaraldehyde. The tissue, procured from cattle originating in the USA is chemically sterilized using ethanol and propylene oxide, and treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. SUPPLE PERI-GUARD is MR safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PC0404SN
In Commercial Distribution

  • 00085412530642 ()
PC0404SNBIO

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0406
In Commercial Distribution

  • 00085412818696 ()
SPG0406

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0404
In Commercial Distribution

  • 00085412818672 ()
SPG0404

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG1016
In Commercial Distribution

  • 00085412818429 ()
SPG1016

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0814
In Commercial Distribution

  • 00085412818375 ()
SPG0814

  • Cardiovascular patch, animal-derived
SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0608
In Commercial Distribution

  • 00085412818313 ()
SPG0608

  • Cardiovascular patch, animal-derived
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable
Surgical Smoke Evacuation System
Buffalo Filter
SV3120V
Not in Commercial Distribution

  • 00851136002549 ()
SV3120V

  • Surgical plume evacuation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Shielded
In Commercial Distribution

  • 17290114061961 ()
  • 07290114061964 ()
STR-921480-00

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

  • 17290114061954 ()
  • 07290114061957 ()
STR-901080-00

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

  • 17290114061947 ()
  • 07290114061940 ()
STR-009081-00

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

  • 17290114061930 ()
  • 07290114061933 ()
STR-009023-00

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

  • 17290114061923 ()
  • 07290114061926 ()
STR-009080-00

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

  • 17290114061916 ()
  • 07290114061919 ()
STR-22675L-00

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

  • 17290114061909 ()
  • 07290114061902 ()
STR-34685L-00

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

  • 17290114061886 ()
  • 07290114061889 ()
STR-001124-00

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

  • 17290114061879 ()
  • 07290114061872 ()
STR-001024-00

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

  • 17290114061862 ()
  • 07290114061865 ()
STR-000024-00

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

  • 17290114061855 ()
  • 07290114061858 ()
STR-000023-00

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

  • 17290114061848 ()
  • 07290114061841 ()
STR-107079-00

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

  • 17290114061831 ()
  • 07290114061834 ()
STR-001079-00

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

  • 17290114061824 ()
  • 07290114061827 ()
STR-000079-00

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

  • 17290114061800 ()
  • 07290114061803 ()
STR-022780-00

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

  • 17290114061794 ()
  • 07290114061797 ()
STR-021480-00

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

  • 17290114061787 ()
  • 07290114061780 ()
STR-007080-00

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

  • 17290114061770 ()
  • 07290114061773 ()
STR-000080-00

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

  • 17290114061534 ()
  • 07290114061537 ()
STR-222291-00

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

  • 17290114061985 ()
  • 07290114061988 ()
STR-090244-00

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

  • 17290114062319 ()
  • 07290114062312 ()
  • 37290114062313 ()
STR-AP9080-00

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

  • 17290114062258 ()
  • 07290114062251 ()
STR-000136-00

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

  • 17290114062241 ()
  • 07290114062244 ()
STR-001080-00

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

  • 17290114062234 ()
  • 07290114062237 ()
STR-000081-00

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

  • 17290114062029 ()
  • 07290114062022 ()
STR-901079-00

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

  • 17290114062012 ()
  • 07290114062015 ()
STR-901024-00

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

  • 17290114062005 ()
  • 07290114062008 ()
STR-009024-00

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

  • 17290114061992 ()
  • 07290114061995 ()
STR-009079-00

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

  • 17290114061978 ()
  • 07290114061971 ()
STR-922780-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega AlphaProbe electrode's cable 10 CH
In Commercial Distribution

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

  • Depth electrode
Prime Calibrator Cartridge CCS Comp 300 Sample
NOVA BIOMEDICAL CORPORATION
PRIME
In Commercial Distribution

  • 00385480524278 ()
52427

  • Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
  • Assisted reproduction centrifuge tube
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode
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