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
ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDA
350M
In Commercial Distribution

  • 07898588841541 ()


  • Orthodontic pliers
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755188574 ()
SA 004.30.550

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188475 ()
C-004.33.537

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188468 ()
C-004.33.536

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188451 ()
C-004.33.535

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188444 ()
C-004.33.534

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188437 ()
C-004.33.533

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188420 ()
C-004.33.532

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188413 ()
C-004.33.531

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188406 ()
C-004.33.530

  • Indirect binocular ophthalmoscope, line-powered
No Description
Heine Optotechnik GmbH & Co. KG
L
In Commercial Distribution

  • 04053755188390 ()
C-004.33.507

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755188185 ()
C-000.33.500

  • Indirect binocular ophthalmoscope
No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5300245
In Commercial Distribution

  • D82853002450 ()


  • Orthodontic palate expander/teeth aligner, bonded
No Description
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5300191
In Commercial Distribution

  • D82853001910 ()


  • Orthodontic retainer
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
4 channels
In Commercial Distribution

  • 17290014954240 ()
  • 07290014954243 ()
STR-000642-44

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2 channels
In Commercial Distribution

  • 17290014954226 ()
  • 07290014954229 ()
STR-000642-22

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

  • 07290114062367 ()
750-000023-00

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

  • 07290114062305 ()
750-000020-00

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

  • 07290114064026 ()
750-000020-00

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

  • 07290014954991 ()
750-000023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
5 channels MER only
In Commercial Distribution

  • 07290014954304 ()
  • 17290014954301 ()
STR-000666-55

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
4 channels MER only
In Commercial Distribution

  • 07290014954298 ()
  • 17290014954295 ()
STR-000666-44

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
3 channels MER only
In Commercial Distribution

  • 07290014954281 ()
  • 17290014954288 ()
STR-000666-33

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2 channels MER only
In Commercial Distribution

  • 07290014954274 ()
  • 17290014954271 ()
STR-000666-22

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1 channel MER only
In Commercial Distribution

  • 07290014954267 ()
  • 17290014954264 ()
STR-000666-11

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
5 channels
In Commercial Distribution

  • 07290014954250 ()
  • 17290014954257 ()
STR-000642-55

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
3 channels
In Commercial Distribution

  • 17290014954233 ()
  • 07290014954236 ()
STR-000642-33

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
1 channel
In Commercial Distribution

  • 17290014954219 ()
  • 07290014954212 ()
STR-000642-11

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

  • 07290014954007 ()
NOM-000000-00

  • Electromyograph
  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114060787 ()
NOW-DFF000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114060770 ()
NOW-DF0000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile electrode's cable
In Commercial Distribution

  • 17290114060926 ()
  • 07290114060929 ()
  • 37290114060920 ()
STR-000730-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 6.0
In Commercial Distribution

  • 07290114060882 ()
750-000025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor
In Commercial Distribution

  • 17290114060865 ()
  • 07290114060868 ()
STR-000075-00

  • Electrical-only medical device connection cable, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type K
In Commercial Distribution

  • 07290114060844 ()
190-000117-14

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

  • 07290114060820 ()
190-000117-12

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

  • 07290114060509 ()
190-000117-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Leksell Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450976 ()
700-020832-00

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

  • 27290016450853 ()
750-02A011-00

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

  • 27290016450846 ()
NOW-020025-00

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

  • 27290016450839 ()
NOW-020021-00

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

  • 27290016450815 ()
700-021507-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexDrive Electrode Holder - Pack of 2
In Commercial Distribution

  • 27290016450242 ()
700-000316-02

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

  • 27290016450099 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive
In Commercial Distribution

  • 27290016450082 ()
NSW-026010-55

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

  • 27290016450068 ()
NNW-006008-55

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

  • 27290014954094 ()
700-020874-00

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

  • 27290016450990 ()
700-020847-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
CRW Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450952 ()
700-020834-00

  • Depth electrode
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