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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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CDS Hematology Calibrator is manufactured for calibration of multi-parameter hematology analyzers for WBC, RBC, Hgb, MCV, Plt and MPV, as applicable to the analyzer system. Multi-parameter hematology analyzers require periodic calibration in order to produce accurate results on patient samples. Calibration may be accomplished by transferring calibration factors to the analyzer through fresh blood samples that have been assayed by reference methods. However, a more direct and convenient approach is to use a calibrator material such as CDS Hematology Calibrator, having system-specific assigned values, derived from a carefully calibrated analyzer or group of analyzers. CDS Hematology Calibrator assigned values are derived from replicate analyses on whole blood calibrated hematology analyzers (see reference procedures). Replicate analyses are performed on the user’s analyzer and calibration factors are computed by comparing recovered values and assigned values. The CDS Hematology Calibrator values are then divided by these determined factors to provide calibration settings for making adjustments to the instrument. Hct, MCH, MCHC, RDW and the WBC differential parameters do not require calibration.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
1 x 4.5mL
In Commercial Distribution

  • 00812137010421 ()
502-068

  • Full blood count IVD, calibrator
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
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm x 56mm.
Shoulder Innovations, Inc.
18mm x 56mm
In Commercial Distribution

  • B1132N1HE180560 ()
2N1HE18056

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Trial Head. 18mm x 48mm.
Shoulder Innovations, Inc.
18mm x 48mm
In Commercial Distribution

  • B1132N1HE180480 ()
2N1HE18048

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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