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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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INS 3058 IS II EMAN US
MEDTRONIC, INC.
3058
In Commercial Distribution

  • 00763000449711 ()


  • Implantable incontinence-control electrical stimulation system pulse generator
Device is a stool collection kit for at-home use.
Geneoscopy, Inc.
0
In Commercial Distribution

  • 00198715728941 ()


  • Faecal specimen collection kit IVD, home-use
The deflation needle is used to drain gastric balloons
PRINCE MEDICAL
SN4000718
In Commercial Distribution

  • 03665039001663 ()
SN4000718

  • Gastrointestinal needle catheter
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
In Commercial Distribution

  • 07630039101404 ()
19880.0005

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
In Commercial Distribution

  • 07630039101398 ()
21362.0102

  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
  • Dermatological extracorporeal shock wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 Tower
Not in Commercial Distribution

  • 07630039101336 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
SD1 T-Top
Not in Commercial Distribution

  • 07630039101329 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
The device is indicated for extracorporeal shock wave treatment.
Storz Medical AG
Intelect F-SW USA
In Commercial Distribution

  • 07630039101312 ()


  • Electromechanical orthopaedic extracorporeal shock wave/pneumatic pressure wave therapy system
This is the Metabolic Solutions Kit version of the kit.
Otsuka America Pharmaceutical Inc
01M
In Commercial Distribution

  • 00857335005039 ()
  • 10857335005043 ()


  • Helicobacter pylori urease IVD, kit, chromogenic
The Micro USB Cable is used to charge Eversense Transmitter
SENSEONICS, INCORPORATED
FG-6000-01-302
In Commercial Distribution

  • 00817491023841 ()


  • Implantable glucose monitoring system transmitter
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