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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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Sure-endo - 08809264299678

Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #00, 19.6 in (50cm)
SURE DENT CORPORATION
SCP-00/S50
In Commercial Distribution

  • 08809264299678 ()


  • Gingival retraction cord, medicated

Sure-endo - 08809264299661

Sure-Cord Plus, Knitted Gingival Retraction Cord with Aluminium Chloride, Size #000, 19.6 in (50cm)
SURE DENT CORPORATION
SCP-000/S50
In Commercial Distribution

  • 08809264299661 ()


  • Gingival retraction cord, medicated

Panoscreen EXTEND - 10888234002406

Panoscreen EXTEND is intended for use in the detection of unexpected red blood cell blood group antibodies.
IMMUCOR, INC.
0002383
In Commercial Distribution

  • 10888234002406 ()


  • Antibody identification panel reagent red blood cell IVD, kit, agglutination

Capture-R Ready-Screen 3 - 10888234001539

Capture-R Ready-Screen (3) is intended for use in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods.
IMMUCOR, INC.
0066901
In Commercial Distribution

  • 10888234001539 ()
0066901

  • Solid-phase red blood cell adherence antibody/antigen IVD

Referencells - 10888234001522

Referencells (Pooled Cells) are intended for use in tube and microplate ABO serum grouping tests.
IMMUCOR, INC.
0066900
In Commercial Distribution

  • 10888234001522 ()
0066900

  • Solid-phase red blood cell adherence antibody/antigen IVD

neXus - 00841626102712

neXus Handpiece Kit (BoneScalpel or SonicOne OR)
MISONIX, INC.
100-21-0000
In Commercial Distribution

  • 00841626102712 ()


  • Hard-tissue ultrasonic surgical system handpiece

neXus - 00841626102668

neXus SonicOne® O.R. Standard Front Housing
MISONIX, INC.
100-21-0003
In Commercial Distribution

  • 00841626102668 ()


  • Ultrasonic surgical system handpiece cooling sleeve

neXus - 00841626102651

neXus BoneScalpel® Standard Front Housing
MISONIX, INC.
100-21-0002
In Commercial Distribution

  • 00841626102651 ()


  • Ultrasonic surgical system handpiece cooling sleeve

neXus - 00841626102521

neXus Standard Handpiece
MISONIX, INC.
100-21-0001
In Commercial Distribution

  • 00841626102521 ()


  • Hard-tissue ultrasonic surgical system handpiece

BoneScalpel - 00841626102057

BoneScalpel Handpiece Kit COMPRISES OF BCM-HP, BCM-SS (MEDICAL DEVICE ) BCM-CBS, BCM-CBL, BCM-CW, BCM-2W, BCM-UM-USB (NON-MEDICAL DEVICES)
MISONIX, INC.
BCM-HP KIT
In Commercial Distribution

  • 00841626102057 ()


  • Hard-tissue ultrasonic surgical system handpiece
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