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
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755153695 ()
C-008.33.502

  • Indirect binocular ophthalmoscope
Ossicular Prosthesis, total
Heinz Kurz GmbH
1004930
In Commercial Distribution

  • EHKM10049301 ()
1004930

  • Ossicular prosthesis, total
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega system
In Commercial Distribution

  • 07290114061506 ()
NOM-000000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954922 ()
750-000070-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954915 ()
750-000020-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
ERBE NESSY® Omega Plate USA (85+23)cm² , with cable 3 m
Erbe Elektromedizin GmbH
20193-084
In Commercial Distribution

  • 04050147015593 ()
  • 04050147005235 ()
  • 04050147017481 ()

  • Area/Surface Area: 85.000 Square centimeter
20193-084

  • Electrosurgical return electrode, single-use
DELTA-9-THC 8 NG/ML
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9THC8NGML5 ()
  • B800DELTA9THC8NGML0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9OMEGA5 ()
  • B800DELTA9OMEGA0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
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