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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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Coagulation Factor X Deficient Plasma - 00842768011030

For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446415
In Commercial Distribution

  • 00842768011030 ()
  • 00842768018817 ()
OTXY13

  • Coagulation factor X IVD, reagent

Coagulation Factor IX Deficient Plasma - 00842768011023

For the determination of the activity of coagulation factor IX in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446414
In Commercial Distribution

  • 00842768011023 ()
  • 00842768018824 ()
OTXX17

  • Coagulation factor IX IVD, reagent

Coagulation Factor VIII Deficient Plasma - 00842768010996

For the determination of the activity of coagulation factor VIII in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446411
In Commercial Distribution

  • 00842768010996 ()
  • 00842768018831 ()
OTXW17

  • Coagulation factor VIII IVD, reagent

DImension Vista® Cystatin C Control L (low) - 00842768006388

CYSC CON L is an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of the CYSC method on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445924
In Commercial Distribution

  • 00842768006388 ()
  • 00842768019371 ()
KC735

  • Plasma protein IVD, control

DImension Vista® Apolipoprotein Calibrator - 00842768006364

For the calibration of APOAI and APOB methods on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445922
In Commercial Distribution

  • 00842768006364 ()
  • 00842768019395 ()
KC720

  • Plasma protein IVD, calibrator

DImension Vista® Protein 1 Control M (medium) - 00842768006340

PROT1 CON M is an assayed, mid-level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445920
In Commercial Distribution

  • 00842768006340 ()
  • 00842768019425 ()
KC716

  • Plasma protein IVD, control

DImension Vista® Protein 1 Control L (low) - 00842768006333

PROT1 CON L is an assayed, low level, intralaboratory, multi-analyte quality control for the assessment of precision and analytical bias on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445919
In Commercial Distribution

  • 00842768006333 ()
  • 00842768019432 ()
KC715

  • Plasma protein IVD, control

DImension Vista® C1 Inhibitor Flex® Reagent Cartridge - 00842768006302

For the quantitative measurement of C1 inhibitor in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445915
Not in Commercial Distribution

  • 00842768006302 ()
  • 00842768020247 ()
K7086

  • Complement component C1 inhibitor IVD, kit, nephelometry/turbidimetry

DImension Vista® Immunoglobulin G Subclass 3 Flex® reagent cartridge - 00842768006289

For the quantitative measurement of immunoglobulin G subclass 3 in human serum and plasma on the Dimension Vista® System
Siemens Healthcare Diagnostics Products GmbH
10445913
In Commercial Distribution

  • 00842768006289 ()
  • 00842768020209 ()
K7082

  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Dade® Ci-Trol® Heparin Control, High - 00842768003905

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445716
In Commercial Distribution

  • 00842768003905 ()
  • 00842768019531 ()
B4224-60

  • Multiple coagulation factor IVD, control

Dade® Ci-Trol® Heparin Control, Low - 00842768003899

Control in heparin assay procedures
Siemens Healthcare Diagnostics Products GmbH
10445715
In Commercial Distribution

  • 00842768003899 ()
  • 00842768019548 ()
B4224-50

  • Multiple coagulation factor IVD, control

Dade® Actin® FSL Activated PTT Reagent - 00842768003882

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445714
In Commercial Distribution

  • 00842768003882 ()
  • 00842768019555 ()
B4219-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FSL Activated PTT Reagent - 00842768003875

Liquid purified soy and rabbit brain phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445713
In Commercial Distribution

  • 00842768003875 ()
  • 00842768019555 ()
B4219-1

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003868

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445712
In Commercial Distribution

  • 00842768003868 ()
  • 00842768019562 ()
B4218-20

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® Activated Cephaloplastin Reagent - 00842768003851

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445711
In Commercial Distribution

  • 00842768003851 ()
  • 00842768019579 ()
B4218-2

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® FS Activated PTT Reagent - 00842768003844

Liquid purified soy phosphatides with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445710
In Commercial Distribution

  • 00842768003844 ()
  • 00842768019562 ()
B4218-100

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Actin® Activated Cephaloplastin Reagent - 00842768003837

Liquid rabbit brain cephalin with plasma activator for coagulation procedures requiring the determination of activated partial thromboplastin time
Siemens Healthcare Diagnostics Products GmbH
10445709
In Commercial Distribution

  • 00842768003837 ()
  • 00842768019579 ()
B4218-1

  • Activated partial thromboplastin time (APTT) IVD, reagent

Dade® Innovin® - 00842768003806

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445706
Not in Commercial Distribution

  • 00842768003806 ()
  • 00842768019586 ()
B4212-50

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00842768003790

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445705
Not in Commercial Distribution

  • 00842768003790 ()
  • 00842768019593 ()
B4212-40

  • Prothrombin time (PT) IVD, reagent

Dade® Innovin® - 00842768003783

For use in prothrombin time (PT) determinations and prothrombin time-based assays in citrated human plasma
Siemens Healthcare Diagnostics Products GmbH
10445704
Not in Commercial Distribution

  • 00842768003783 ()
  • 00842768019609 ()
B4212-100

  • Prothrombin time (PT) IVD, reagent

Dade® PFA Trigger Solution - 00842768003691

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445701
In Commercial Distribution

  • 00842768003691 ()
  • 00842768019791 ()
B4170-50

  • Platelet aggregation study IVD, reagent

Dade® PFA Collagen/ADP Test Cartridge - 00842768003684

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445699
In Commercial Distribution

  • 00842768003684 ()
  • 00842768019784 ()
B4170-21A

  • Platelet aggregation study IVD, reagent

Dade® PFA Collagen/EPI Test Cartridge - 00842768003660

To aid in the detection of platelet dysfunction in citrated human whole blood
Siemens Healthcare Diagnostics Products GmbH
10445697
In Commercial Distribution

  • 00842768003660 ()
  • 00842768019777 ()
B4170-20A

  • Platelet aggregation study IVD, reagent

IMAGE DIAGNOSTICS, INC - 00850061871190

IDI,RADIATION SHIELD SYSTEM,PROTEGO,PROLITE TABLE MOUNT,METRIC ACCESSORY RAILS,SIEMENS ICONO TABLE#A800-0471-SII
IMAGE DIAGNOSTICS, INC.
Protego ProLite System for Siemens Icono Tables
In Commercial Distribution

  • 00850061871190 ()
A800-0471-SII

  • Radiation shielding curtain

IMAGE DIAGNOSTICS, INC - 00850061871183

IDI,RADIATION SHIELD SYSTEM,PROTEGO,PROLITE TABLE MOUNT,METRIC ACCESSORY RAILS,SIEMENS ARTIS TABLE#A800-0471-SIA
IMAGE DIAGNOSTICS, INC.
Protego ProLite System for Siemens Artis Tables
In Commercial Distribution

  • 00850061871183 ()
A800-0471-SIA

  • Radiation shielding curtain

Needle Guide - 10841436105146

Sterile endocavity needle guide for use with Esaote EC1123, SE3123 and Siemens EC1123 ultrasound transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
639-012
In Commercial Distribution

  • 00841436105415 ()
  • 10841436105146 ()

  • Length: 5.48 Inch
  • Height: 0.97 Inch
639-012

  • Needle guide, single-use

Needle Guide - 10841436100486

Sterile quick-release endocavity needle guide with 16-18GA, 20-22GA inserts for use with Siemens EV10-5 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10787095
In Commercial Distribution

  • 00841436100489 ()
  • 10841436100486 ()

  • Height: 0.87 Inch
  • Length: 6.1 Inch
10787095

  • Needle guide, single-use

Needle Guide - 00841436121415

Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Siemens 10EV3 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
11504340
In Commercial Distribution

  • 20841436121426 ()
  • 00841436121415 ()
11504340

  • Needle guide, reusable

Biopsy Bracket - 00841436112215

Reusable non-sterile Verza™ bracket for use with Siemens Healthineers 14L5 (Model No. 11254090) transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
676-209
In Commercial Distribution

  • 00841436112215 ()
  • 20841436115838 ()
676-209

  • Ultrasound imaging system tracking positioner, reusable

Biopsy Bracket - 00841436100243

Reusable non-sterile multi-angle bracket with cleaning brushes (5) for use with Siemens 18L6 HD transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
10044759
In Commercial Distribution

  • 00841436100243 ()
  • 20841436115586 ()

  • Height: 1.91 Inch
  • Length: 4.03 Inch
10044759

  • Ultrasound imaging system tracking positioner, reusable
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