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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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IF Sprinter (model IFA/ELISA) - 04049016100591

No Description
EUROIMMUN Medizinische Labordiagnostika AG
YG 0032-0101-2
Not in Commercial Distribution

  • 04049016100591 ()


  • Enzyme immunoassay (EIA) analyser IVD
  • Laboratory diluter

Tandem Mobi Adhesive Sleeve - 00389152076256

No Description
Tandem Diabetes Care, Inc.
1010762
In Commercial Distribution

  • 00389152000961 ()
  • 00389152076256 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

Tandem Mobi Adhesive Sleeve - 00389152076157

No Description
Tandem Diabetes Care, Inc.
1010123
In Commercial Distribution

  • 00389152000961 ()
  • 00389152076157 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm

n.a. - 04048551273487

Suction Burr
Karl Storz GmbH & Co. KG
41201FD
In Commercial Distribution

  • 04048551273487 ()


  • ENT shaver system

Intuy - 00194711121021

Intuy Knee System (ILK), Silver Color
Willowwood Global LLC
WW-1LK-1W
In Commercial Distribution

  • 00194711121021 ()
WW-1LK-1W

  • Mechatronic external knee prosthesis

Intuy - 00194711121014

Intuy Knee System (ILK), Black Color
Willowwood Global LLC
WW-1LK-1B
In Commercial Distribution

  • 00194711121014 ()
WW-1LK-1B

  • Mechatronic external knee prosthesis

NA - 03596010250650

MTO HARNESS REPLACEMT PS3500EP C/U
Smith & Nephew, Inc.
7204890
Not in Commercial Distribution

  • 03596010250650 ()
7204890

  • Arthroscopic shaver system, electrically-powered

MagStand 1.5 - 00840682138826

No Description
GE MEDICAL SYSTEMS
MAG5
In Commercial Distribution

  • 00840682138826 ()


  • Stationary mammographic x-ray system, digital

MagStand 1.8 - 00840682138802

No Description
GE MEDICAL SYSTEMS
MAG8
In Commercial Distribution

  • 00840682138802 ()


  • Stationary mammographic x-ray system, digital

Push-in connectors for PU tubes - 03701354407008

Push-in connectors for PU tubes
PLASMABIOTICS
RR-DY68
In Commercial Distribution

  • 03701354407008 ()

  • Length: 20 Centimeter
  • Width: 12 Centimeter
  • Height: 3 Centimeter


  • Endoscope clean-storage system
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