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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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X-GUIDE - 00817421021527

ADAPTOR SLEEVE - 5
XNAV TECHNOLOGIES LLC
P010720
In Commercial Distribution

  • 00817421021527 ()


  • Surgical planning/navigation-enhancement system

Vision 2 - 00817978022053

Salmonella H: 5
PRO-LAB, INCORPORATED
PLA205
In Commercial Distribution

  • 00817978022053 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978020844

Salmonella O:5
PRO-LAB, INCORPORATED
PLA084
In Commercial Distribution

  • 00817978020844 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

TriplePlay - 00817377022753

iFM - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40322-0001
In Commercial Distribution

  • 00817377022753 ()


  • Polysomnograph

TriplePlay - 00817377021190

FM5 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40312-0001
In Commercial Distribution

  • 00817377021190 ()


  • Polysomnograph

TriplePlay - 00817377021145

FM4 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40302-0001
In Commercial Distribution

  • 00817377021145 ()


  • Polysomnograph

TriplePlay - 00817377021077

FM3 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40205-0001
In Commercial Distribution

  • 00817377021077 ()


  • Polysomnograph

TriplePlay - 00817377021060

FM2 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-40204-0001
In Commercial Distribution

  • 00817377021060 ()


  • Polysomnograph

TriplePlay - 00817377020872

FM1 - Alice 5
DYMEDIX DIAGNOSTICS, INC.
12-10003-0001
In Commercial Distribution

  • 00817377020872 ()


  • Polysomnograph

Sequel Medical - 00810071321443

5 hole Cube
Sequel Medical Inc.
IM01-4445
In Commercial Distribution

  • 00810071321443 ()
IM01-4445

  • External orthopaedic fixation system, single-use
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