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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No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP05X-0ME
In Commercial Distribution

  • 00841823107268 ()
RD10R-SP05X-0ME

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP05X-000
In Commercial Distribution

  • 00841823107251 ()
RD10R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP04X-000
In Commercial Distribution

  • 00841823107244 ()
RD10R-SP04X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD10R-SP03X-000
In Commercial Distribution

  • 00841823107237 ()
RD10R-SP03X-000

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

  • 00841823107220 ()
RD08R-SP05X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD08R-SP04X-000
In Commercial Distribution

  • 00841823107213 ()
RD08R-SP04X-000

  • Depth electrode
No Description
Ad-Tech Medical Instrument Corporation
RD06R-SP05X-000
In Commercial Distribution

  • 00841823107206 ()
RD06R-SP05X-000

  • Depth electrode
Rotation Block
SEASPINE ORTHOPEDICS CORPORATION
25-40-0330
In Commercial Distribution

  • 10889981114800 ()
25-40-0330

  • Bone graft packing block
Screw Sizing Block
SEASPINE ORTHOPEDICS CORPORATION
25-40-0165
In Commercial Distribution

  • 10889981114640 ()
25-40-0165

  • Bone graft packing block
STARGATE NM GANTRY FINAL
G E MEDICAL SYSTEMS ISRAEL LTD.
H3911AB
In Commercial Distribution

  • 00195278118295 ()


  • Stationary gamma camera system
  • Full-body CT system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061142 ()
700-021508-00

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

  • 27290014954100 ()
700-021508-00

  • 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.
Sterile Neuro Omega AlphaProbe electrode's cable 10 CH
In Commercial Distribution

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

  • 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

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

  • 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.
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
Surgical Smoke Evacuation System
Buffalo Filter
SV3120V
Not in Commercial Distribution

  • 00851136002549 ()
SV3120V

  • Surgical plume evacuation system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable
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
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