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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
Aktina Corp.
60-312
In Commercial Distribution

  • B365603120 ()


  • Radiological compression belt
No Description
Aktina Corp.
60-311
In Commercial Distribution

  • B365603110 ()


  • Radiological compression belt
No Description
Aktina Corp.
60-310
In Commercial Distribution

  • B365603100 ()


  • Radiological compression belt
No Description
Aktina Corp.
11-202
In Commercial Distribution

  • B365112020 ()


  • Radiological whole-body positioner
15ga, 30 cm single leader catheters with colored button, 5/pack
Liberty Medical , Inc.
5653
In Commercial Distribution

  • B16556530326033124037 ()


  • General-purpose brachytherapy system applicator, manual
15ga single leader catheter with colored button, 1/pack
Liberty Medical , Inc.
5641
In Commercial Distribution

  • B16556450326083124107 ()


  • General-purpose brachytherapy system applicator, manual
15ga single leader catheter with colored button, 5/pack
Liberty Medical , Inc.
5641
In Commercial Distribution

  • B16556410326093024120 ()


  • General-purpose brachytherapy system applicator, manual
15ga single leader catheter with colored button, 5/pack
Liberty Medical , Inc.
5641
In Commercial Distribution

  • B16556410326033124042 ()


  • General-purpose brachytherapy system applicator, manual
CAPILLAROSCOPE WITH PROFESSIONAL SW (500x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-319
Not in Commercial Distribution

  • B1623191 ()
FEDMEDMICFIT6SWC_US

  • Otoscope, direct
CAPILLAROSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-317
Not in Commercial Distribution

  • B1623171 ()
FEDMEDMICFISTDSWC_US

  • Otoscope, direct
DEMATOSCOPE WITH PROFESSIONAL SW (10X-90x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-316
Not in Commercial Distribution

  • B1623161 ()
FEDMEDMICFIUVWPSWD_US

  • Otoscope, direct
DEMATOSCOPE WITH PROFESSIONAL SW (5X-200x)
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-314
Not in Commercial Distribution

  • B1623141 ()
FEDMEDMICFIPSWD_US

  • Otoscope, direct
15ga single leader catheter with female luer and button, 1/pack
Liberty Medical , Inc.
6039
In Commercial Distribution

  • B1656039032610124134 ()


  • General-purpose brachytherapy system applicator, manual
15ga single leader catheter with female luer and button, 1/pack
Liberty Medical , Inc.
6039
In Commercial Distribution

  • B16560390326093024113 ()


  • General-purpose brachytherapy system applicator, manual
No Description
Biomet Orthopedics, LLC
909848
In Commercial Distribution

  • 00887868572531 ()
909848

  • Ligament reconstruction instrument set, reusable
Disposable PEEP valve with converter to be used with manual resuscitators.
B.L.S. Systems Limited
4000-PVC
In Commercial Distribution

  • B0024000PVC0 ()
  • B0024000PVC2 ()
4000-PVC

  • PEEP valve, single-use
CPR faceshield with one way valve
B.L.S. Systems Limited
2030
In Commercial Distribution

  • B00220300 ()
  • B00220305 ()
2030

  • Cardiopulmonary resuscitation mask, single-use
Rescuer disposable CPR mask with oxygen inlet, head strap, one way valve, hard shell case and 2 nitrile gloves
B.L.S. Systems Limited
2025-HS-CCX
In Commercial Distribution

  • B0022025HSCCX0 ()
  • B0022025HSCCX8 ()
2025-HS-CCX

  • Cardiopulmonary resuscitation mask, single-use
Rescuer Disposable CPR face mask with one way valve.
B.L.S. Systems Limited
2000
In Commercial Distribution

  • B00220000 ()
2000

  • Cardiopulmonary resuscitation mask, single-use
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114063016 ()
NSW-026010-55

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

  • 27290114062408 ()
NNW-026000-55

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

  • 27290114062392 ()
NNW-006010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060916 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060909 ()
NNW-006008-55

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

  • 27290114060442 ()
NSW-006008-55

  • 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.
Neuro Omega with NeuroFortis Drive
In Commercial Distribution

  • 27290016450105 ()
NOW-020070-00

  • 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.
NeuroNav with Autoclavable Drive Headstage
In Commercial Distribution

  • 27290016450068 ()
NNW-006008-55

  • Depth electrode
No Description
MAZOR ROBOTICS LTD
TOL0078-01
In Commercial Distribution

  • 07290109183770 ()


  • Stereotactic surgery system probe, reusable
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