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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
Roche Diagnostics GmbH
05917824160
In Commercial Distribution

  • 04015630927807 ()
05917824160

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
SEBIA
4115
In Commercial Distribution

  • 03607360041154 ()
4115

  • Protein electrophoresis IVD, kit, electrophoresis
No Description
SEBIA
4787
In Commercial Distribution

  • 03607360047873 ()
4787

  • Protein electrophoresis IVD, control
No Description
SEBIA
4785
In Commercial Distribution

  • 03607360047859 ()
4785

  • Protein electrophoresis IVD, control
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-5OB
In Commercial Distribution

  • 20722355002198 ()
  • 10722355002238 ()
  • 80722355002237 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
MaxSupport 5, wideshaped, red, neutral position
MACROMEDICS B.V.
HS5
In Commercial Distribution

  • 08719425700793 ()
117150

  • Indexed-immobilization patient positioning system
No Description
HYPHEN BIOMED
221105
In Commercial Distribution

  • 03663537008214 ()
221105

  • Antithrombin III (ATIII) IVD, kit, chromogenic
crea.lign Opaker 5 C2/C3/D2/D4 4 g
bredent GmbH & Co. KG
CLFHOP05
In Commercial Distribution

  • EBRECLFHOP059 ()
  • EBRECLFHOP050 ()
CLFHOP05

  • Dental veneer, professional
5 Scraper box
MC BIO SRL
9572510
In Commercial Distribution

  • 08057639710635 ()


  • Instrument tray, reusable
The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ,PointerShell. The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation System using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where, reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0129011 ()
  • EFIAE0129010 ()


  • Multi-purpose stereotactic surgery system
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