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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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SHUNT 1156505 AUSTIN ENDOLYMPHATIC
MEDTRONIC XOMED, INC.
1156505
Not in Commercial Distribution

  • 00681490035897 ()

  • Chamber Length is 3.5 MM
  • Length: 18.0 Millimeter
  • Chamber Diameter is 2.0 MM


  • Endolymphatic shunt
SHUNT 1156404 AUSTIN ENDOLYMPHATIC
MEDTRONIC XOMED, INC.
1156404
In Commercial Distribution

  • 00681490035798 ()

  • Chamber Diameter is 2.0 MM
  • Chamber Length is 3.5 MM
  • Length: 18.0 Millimeter


  • Endolymphatic shunt
This is the outer label for the box that contains 20 3C Patch Deviceds and the IFU.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188505619 ()


  • Haematological concentrate system preparation kit, platelet concentration
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
This is the outer label for the box that includes 12 3C Patch Kits and the IFU.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188505541 ()


  • Haematological concentrate system preparation kit, platelet concentration
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
This is the outer label for the box that contains 20 venipuncture needle sets (commercially available), 20 3C Patch Needle Holder, and the IFU.
Reapplix ApS
1
Not in Commercial Distribution

  • 05714188505220 ()


  • Haematological concentrate system preparation kit, platelet concentration
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
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
Used to attach and hold the 3C Patch Device with the supplied venipuncture set.
Reapplix ApS
2
In Commercial Distribution

  • 05714188501000 ()


  • Haematological concentrate system preparation kit, platelet concentration
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