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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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Inion Hexalon™ Instrumentation - 06438408012020

RapidNotcher
Inion Oy
2
In Commercial Distribution

  • 06438408012020 ()
INS-9207

  • Orthopaedic bur, 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

3C Patch® Kit - 05714188505008

Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available).
Reapplix ApS
2
In Commercial Distribution

  • 05714188505008 ()


  • Haematological concentrate system preparation kit, platelet concentration

3C Patch® Device - 05714188502106

Holds the blood at collection and during processing in the centrifuge.
Reapplix ApS
2
In Commercial Distribution

  • 05714188502106 ()


  • Haematological concentrate system preparation kit, platelet concentration
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