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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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Lunette blue model 2 - 06430024461022

The Lunette menstrual cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Lune Group Oy Ltd
2
In Commercial Distribution

  • 06430024461022 ()


  • Menstrual cup, non-latex, reusable

Lunette clear model 2 - 06430024460025

The Lunette Menstrual Cup is a receptacle placed in the vagina to collect blood and cellular debris that is extruded from the uterus via the cervix during menstruation.
Lune Group Oy Ltd
2
In Commercial Distribution

  • 06430024460025 ()


  • Menstrual cup, non-latex, reusable

ICP - 00688162000467

Stretcher Sheet, White, SMS 96x37
ICP MEDICAL, LLC
2
In Commercial Distribution

  • 10688162000464 ()
  • 00688162000467 ()
  • 20688162000461 ()

  • Length: 96 Inch
  • Width: 37 Inch
ICP-9001GUR

  • Waterproof bed mattress cover, reusable

Blood Product Administration Module - 00860475000345

No Description
EPIC SYSTEMS CORPORATION
2
In Commercial Distribution

  • 00860475000345 ()


  • Blood bank information system application software

vRad PACS - 00862234000313

vRad PACS 2
Vrad
2
In Commercial Distribution

  • 00862234000313 ()


  • Radiological PACS software

VMA - 00868579000209

No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution

  • 00868579000209 ()


  • Diagnostic x-ray digital imaging system workstation

ImPACT Quick Test - 00864127000356

ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software

3C Patch® Device - Extra Component Set - 05714188505602

This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.
Reapplix ApS
2
Not in Commercial Distribution

  • 05714188505602 ()


  • Haematological concentrate system preparation kit, platelet concentration

Box - 3C Patch® Kit - 05714188505503

This is the outer label for the box that includes 12 3C Patch® Kits and the IFU.
Reapplix ApS
2
In Commercial Distribution

  • 05714188505503 ()


  • Haematological concentrate system preparation kit, platelet concentration

4 x (21G Needle + 3C Patch® Needle Holder) - 05714188505206

This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders.
Reapplix ApS
2
In Commercial Distribution

  • 05714188505206 ()


  • Haematological concentrate system preparation kit, platelet concentration
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