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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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T-HANDLE WITH QC FOR IM REDUCTION TOOLS
Synthes GmbH
SD360.249
In Commercial Distribution

  • H679SD3602490 ()
  • 10886982006479 ()
SD360249

  • Surgical instrument handle, non-torque-limiting
MGUIDE tools kit for coni. con. implant
MIS Implants Technologies Ltd.
MG-KT04
In Commercial Distribution

  • 07290109013602 ()
MG-KT04

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Guided Tools extender for 4.70 mm Hex.
MIS Implants Technologies Ltd.
MG1-TE480
In Commercial Distribution

  • 07290109013138 ()
MG1-TE480

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BONE ACCESS TOOLS T25R VALUE BONE ACCESS
MEDTRONIC SOFAMOR DANEK, INC.
T25R
In Commercial Distribution

  • 00763000026721 ()


  • Bone access cannula
Mednet Software
ICU MEDICAL, INC.
6.31.01
In Commercial Distribution

  • 10887787009139 ()
160379202

  • Infusion pump medication-dosage application software
Mednet Software
ICU MEDICAL FLEET SERVICES, LLC
6.30.01
In Commercial Distribution

  • 10887787009115 ()
160379201

  • Infusion pump medication-dosage application software
Metnet Software
HOSPIRA, INC.
6.20.01
In Commercial Distribution

  • 10887787001751 ()
160376404

  • Infusion pump medication-dosage application software
EncoreBasic Software
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049284 ()
1068689

  • Medical equipment clinical data interfacing software
EncoreBasic Software
Respironics, Inc.
2.12
In Commercial Distribution

  • 00606959052406 ()
1068689

  • Medical equipment clinical data interfacing software
EncoreBasic Software
Respironics, Inc.
EncoreBasic Software - 2
In Commercial Distribution

  • 00606959046962 ()
1068689

  • Medical equipment clinical data interfacing software
EncoreBasic Software
Respironics, Inc.
2.9
In Commercial Distribution

  • 00606959039667 ()
1068689

  • Medical equipment clinical data interfacing software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
51529
In Commercial Distribution

  • 09008738515293 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
50898
Not in Commercial Distribution

  • 09008738508981 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
98330
Not in Commercial Distribution

  • 09008737983307 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
53106
In Commercial Distribution

  • 09008737531065 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52585
In Commercial Distribution

  • 09008737525859 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52581
In Commercial Distribution

  • 09008737525811 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
52503
In Commercial Distribution

  • 09008737525033 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
42172
In Commercial Distribution

  • 09008737421724 ()


  • Audiometric/hearing device software
Fitting Software
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
40291
In Commercial Distribution

  • 09008737402914 ()


  • Audiometric/hearing device software
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