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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
BIOTRONIK SE & Co. KG
383584
Not in Commercial Distribution

  • 04035479125400 ()
383584

  • Single-chamber implantable defibrillator
No Description
BIOTRONIK SE & Co. KG
383568
Not in Commercial Distribution

  • 04035479125240 ()
383568

  • Dual-chamber implantable defibrillator
No Description
ergoline GmbH
191002.T
Not in Commercial Distribution

  • 04059358001630 ()


  • Bicycle ergometer
No Description
ergoline GmbH
191002.P
Not in Commercial Distribution

  • 04059358001623 ()


  • Bicycle ergometer
No Description
ergoline GmbH
191002
In Commercial Distribution

  • 04059358001616 ()


  • Bicycle ergometer
No Description
BIOCARE MEDICAL LLC
ACI3025C
In Commercial Distribution

  • 00847627002693 ()


  • Cytokeratin IVD, antibody
No Description
BIOCARE MEDICAL LLC
ACI3025A
In Commercial Distribution

  • 00847627002686 ()


  • Cytokeratin IVD, antibody
Twist Drill, 5/16”
SYMMETRY MEDICAL INC.
11-001-400
In Commercial Distribution

  • 00847538007961 ()
2709-01-015;00-9986-010-26;430032

  • Fluted surgical drill bit, reusable
No Description
BIOCARE MEDICAL LLC
API3025AA
In Commercial Distribution

  • 00847627003959 ()


  • Cytokeratin IVD, antibody
The Global Reference Module 5 provides Global Referencing to the ATLAS Neurophysiology System. It connects to the Global Reference Connection on the ATLAS Combo Board.
NEURALYNX, INC.
Global Reference Module - 5
In Commercial Distribution

  • 00850011306550 ()
31-0604-0047

  • Electroencephalographic signal amplifier
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