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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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TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
SMEC25S
In Commercial Distribution

  • 50850025153404 ()
  • 10850025153406 ()
  • 00850025153409 ()
SMEC25S

  • Urinary incontinence penis sheath/port, single-use
External Pulse Generator, 2 Port Header
ADVANCED NEUROMODULATION SYSTEMS, INC.
3042
In Commercial Distribution

  • 05415067051882 ()
3042

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
DRG External Pulse Generator, 8 Channel
ST. JUDE MEDICAL, INC.
7599
In Commercial Distribution

  • 05415067027122 ()
7599

  • Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator
DBS External Pulse Generator, 16 Channel
ST. JUDE MEDICAL, INC.
6599
In Commercial Distribution

  • 05415067023667 ()
6599

  • Deep brain electrical stimulation system
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC41X
In Commercial Distribution

  • 10850025153499 ()
  • 00850025153492 ()
  • 50850025153497 ()
EMEC41X

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC36L
In Commercial Distribution

  • 10850025153482 ()
  • 00850025153485 ()
  • 50850025153480 ()
EMEC36L

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC32N
In Commercial Distribution

  • 50850025153473 ()
  • 10850025153475 ()
  • 00850025153478 ()
EMEC32N

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC29M
In Commercial Distribution

  • 10850025153468 ()
  • 00850025153461 ()
  • 50850025153466 ()
EMEC29M

  • Urinary incontinence penis sheath/port, single-use
TruCath 100% silicone Male external catheter
HR PHARMACEUTICALS INC.
EMEC25S
In Commercial Distribution

  • 50850025153459 ()
  • 10850025153451 ()
  • 00850025153454 ()
EMEC25S

  • Urinary incontinence penis sheath/port, single-use
PROG-003 External Power Accessories Kit (US)
Avertix Medical Inc.
0204-2100-093#P10
In Commercial Distribution

  • 00850012625100 ()
0204-2100-093#P10

  • Implantable cardiac device management application software
Solo Pace Control External Pulse Generator
SOLO PACE INC.
SOLOEPG1L
In Commercial Distribution

  • 00850056280037 ()


  • External pacemaker, epicardial pacing
Defibrilator/AED Tester, External Pacer Analyzer
FLUKE ELECTRONICS CORPORATION
IMPULSE 7000DP
In Commercial Distribution

  • 00850540007126 ()
2811919

  • External defibrillator tester
CABLE, EXTERNAL BATTERY EXTENSION, 1000 MM
MOBIUS BIONICS LLC
LU-60072-1000
In Commercial Distribution

  • 00859503006497 ()


  • Myoelectric hand prosthesis
CABLE, EXTERNAL BATTERY EXTENSION, 500 MM
MOBIUS BIONICS LLC
LU-60072-0500
In Commercial Distribution

  • 00859503006480 ()


  • Myoelectric hand prosthesis
NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET
NATUS MEDICAL INCORPORATED
NT821705
In Commercial Distribution

  • 00382830050517 ()


  • Intracerebral infusion/drainage catheter, short-term
TrexHD/Quantum II External Battery Pack
XLTEK
018795
In Commercial Distribution

  • 00382830047111 ()
018795

  • Electroencephalograph
External Functional Neuromuscular Stimulator (8 channels)
HASOMED GmbH
FES01050
In Commercial Distribution

  • 04260397620427 ()
FES01050

  • Gait-enhancement electrical stimulation system, external
393.76 @OPEN COMPRESSOR FOR LG EXTERNAL
MEDLINE INDUSTRIES, INC.
39376RH
In Commercial Distribution

  • 10888277692770 ()
39376RH

  • External orthopaedic fixation system reprocessed component
External Tibial Alignment guide ANKLE CLAMP
Omni Life Science, Inc.
KS-70005
In Commercial Distribution

  • 00841690190219 ()
KS-70005

  • Joint prosthesis implantation kit, reusable
MANDIBLE EXTERNAL FIXATOR 500MM ROD KIT-STERILE
Synthes GmbH
03.305.500S
In Commercial Distribution

  • H98003305500S0 ()
  • 10887587010069 ()
03305500S

  • External orthopaedic fixation system, reusable
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