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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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For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control
For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Tri-Level is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
6 x 4.5mL
In Commercial Distribution

  • 00812137010216 ()
  • 00812137011794 ()
501-605

  • Full blood count IVD, control
Diamond FG
EDENTA ETABLISSEMENT
EDENTA SET X
In Commercial Distribution

  • E312EDENTASETX101 ()
  • E312EDENTASETX1 ()


  • Diamond dental bur, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 56mm
Shoulder Innovations, Inc.
21mm x 56mm
In Commercial Distribution

  • B1132N1HE210560 ()
2N1HE21056

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 52mm.
Shoulder Innovations, Inc.
21mm x 52mm
In Commercial Distribution

  • B1132N1HE210520 ()
2N1HE21052

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 50mm
Shoulder Innovations, Inc.
21mm x 50mm
In Commercial Distribution

  • B1132N1HE210500 ()
2N1HE21050

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mmx 48mm.
Shoulder Innovations, Inc.
21mm x 48mm
In Commercial Distribution

  • B1132N1HE210480 ()
2N1HE21048

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm x 44mm
Shoulder Innovations, Inc.
21mm x 44mm
In Commercial Distribution

  • B1132N1HE210440 ()
2N1HE21044

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 20mm x 52mm
Shoulder Innovations, Inc.
20mm x 52mm
In Commercial Distribution

  • B1132N1HE200520 ()
2N1HE20052

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 19mm x 50mm
Shoulder Innovations, Inc.
19mm x 50mm
In Commercial Distribution

  • B1132N1HE190500 ()
2N1HE19050

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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