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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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Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad - 00817100020209

Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPAL 02-04-04-000
In Commercial Distribution

  • 00817100020209 ()


  • Diagnostic x-ray digital imaging system workstation

Konica Minolta SW (Acquire) Opal, 20/20 Opal (Acquire) Vizion - 00817100020186

Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution

  • 00817100020186 ()


  • Diagnostic x-ray digital imaging system workstation application software

Zn - 03573026588731

Zn is a reagent associated to API 20 E® (20 100) API 20 NE® (20 050) API 50 CH® (50 300) API 50 CHB/E® (50 430)
BIOMERIEUX SA
Zn
In Commercial Distribution

  • 03573026099534 ()
  • 03573026588731 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, reagent

ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG - 07898671250496

KIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, AND DIAPHRAGM FOR USE WITH OXYMAG, SINGLE-USE
MAGNAMED TECNOLOGIA MEDICA SA
1709953
In Commercial Distribution

  • 07898671250496 ()
1709953

  • Breathing circuit gas-flow sensor, single-use
  • Mechanical expiratory valve, single-use

NIN - 03573026141974

NIN is a reagent associated to API® 20 Strep (20 600), API® Campy (20 800), rapid ID 32 STREP (32 600)
BIOMERIEUX SA
70491
In Commercial Distribution

  • 03573026141974 ()


  • Multiple aerobic gram positive bacteria species culture isolate identification IVD, reagent

ORTHOPEDIC SALVAGE SYSTEM (OSS) - 00880304674714

No Description
Biomet Orthopedics, LLC
151835
In Commercial Distribution

  • 00880304674714 ()

  • 20 MM
151835

  • Orthopaedic bone screw, non-bioabsorbable, sterile

ARCOS - 00880304483385

No Description
Biomet Orthopedics, LLC
31-300570
In Commercial Distribution

  • 00880304483385 ()

  • SIZE 20
31-300570

  • Bone-resection orthopaedic reamer, reusable

RINGLOC + HIP SYSTEM - 00880304512054

No Description
Biomet Orthopedics, LLC
106020
In Commercial Distribution

  • 00880304512054 ()

  • 20 SIZE
106020

  • Acetabular shell

EXPLOR® RADIAL HEAD PLATING SYSTEM - 00880304826588

No Description
Biomet Orthopedics, LLC
IFI-491422
In Commercial Distribution

  • 00880304826588 ()

  • 20 MM
IFI-491422

  • Implant handling forceps, scissors-like

No-Profile - 00880304405769

No Description
Biomet Orthopedics, LLC
904420
In Commercial Distribution

  • 00880304405769 ()

  • 20 MM
904420

  • Tendon/ligament bone anchor, non-bioabsorbable

INSERTER PLATE W/POST - 00880304372375

No Description
Biomet Orthopedics, LLC
423690
In Commercial Distribution

  • 00880304372375 ()

  • 20 MM
423690

  • Orthopaedic inorganic implant inserter/extractor, reusable

SeaSpine Spacer System - Ventura™ NanoMetalene® - 10889981050153

Ventura NM MIS Inserter, 20 Deg
Seaspine Orthopedics Corporation
93-3802
In Commercial Distribution

  • 10889981050153 ()

  • 20 degrees
93-3802

  • Orthopaedic inorganic implant inserter/extractor, reusable

SureFISH 13q14.2 RB1 522kb P20 GR - 05700574037420

SureFISH 13q14.2 RB1 522kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110283G
In Commercial Distribution

  • 05700574037420 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 9p24.3 Chr9pTel 428kb P20 GR - 05700574036836

SureFISH 9p24.3 Chr9pTel 428kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110898G
Not in Commercial Distribution

  • 05700574036836 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 8p23.3 Chr8pTel 406kb P20 GR - 05700574036829

SureFISH 8p23.3 Chr8pTel 406kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110896G
Not in Commercial Distribution

  • 05700574036829 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 7p22.3 Chr7pTel 426kb P20 GR - 05700574036812

SureFISH 7p22.3 Chr7pTel 426kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110895G
Not in Commercial Distribution

  • 05700574036812 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 5q35.3 Chr5qTel 397kb P20 GR - 05700574036805

SureFISH 5q35.3 Chr5qTel 397kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110892G
Not in Commercial Distribution

  • 05700574036805 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 2q37.3 Chr2qTel 415kb P20 GR - 05700574036799

SureFISH 2q37.3 Chr2qTel 415kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110885G
Not in Commercial Distribution

  • 05700574036799 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 1p36.33 Chr1pTel 417kb P20 GR - 05700574036782

SureFISH 1p36.33 Chr1pTel 417kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110882G
Not in Commercial Distribution

  • 05700574036782 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 16q24.3 Chr16qTel 424kb P20 GR - 05700574036775

SureFISH 16q24.3 Chr16qTel 424kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110877G
Not in Commercial Distribution

  • 05700574036775 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 16p13.3 Chr16pTel 428kb P20 GR - 05700574036768

SureFISH 16p13.3 Chr16pTel 428kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110876G
Not in Commercial Distribution

  • 05700574036768 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 9q34.3 Chr9qTel 429kb P20 GR - 05700574036751

SureFISH 9q34.3 Chr9qTel 429kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110861G
Not in Commercial Distribution

  • 05700574036751 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 3p26.3 Chr3pTel 381kb P20 GR - 05700574036744

SureFISH 3p26.3 Chr3pTel 381kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110860G
Not in Commercial Distribution

  • 05700574036744 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 2p25.3 Chr2pTel 391kb P20 GR - 05700574036737

SureFISH 2p25.3 Chr2pTel 391kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110859G
Not in Commercial Distribution

  • 05700574036737 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 10q26.3 Chr10qTel 391kb P20 GR - 05700574036720

SureFISH 10q26.3 Chr10qTel 391kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110857G
Not in Commercial Distribution

  • 05700574036720 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 10p15.3 Chr10pTel 372kb P20 GR - 05700574036713

SureFISH 10p15.3 Chr10pTel 372kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110856G
Not in Commercial Distribution

  • 05700574036713 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 15q26.3 Chr15qTel 391kb P20 GR - 05700574036706

SureFISH 15q26.3 Chr15qTel 391kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110855G
Not in Commercial Distribution

  • 05700574036706 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 7q36.3 Ch7qTel 396kb P20 GR - 05700574036690

SureFISH 7q36.3 Ch7qTel 396kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110854G
Not in Commercial Distribution

  • 05700574036690 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 3q29 Chr3qTel 380kb P20 GR - 05700574036683

SureFISH 3q29 Chr3qTel 380kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110853G
Not in Commercial Distribution

  • 05700574036683 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 1q44 Chr1qTel 402kb P20 GR - 05700574036676

SureFISH 1q44 Chr1qTel 402kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110852G
Not in Commercial Distribution

  • 05700574036676 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 14q32.33 Chr14qTel 415kb P20 GR - 05700574036669

SureFISH 14q32.33 Chr14qTel 415kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110851G
Not in Commercial Distribution

  • 05700574036669 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 22q13.33 Chr22qTel 383kb P20 GR - 05700574036652

SureFISH 22q13.33 Chr22qTel 383kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110850G
Not in Commercial Distribution

  • 05700574036652 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 20q13.33 Chr20qTel 379kb P20 GR - 05700574036645

SureFISH 20q13.33 Chr20qTel 379kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110849G
Not in Commercial Distribution

  • 05700574036645 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 20p13 Chr20pTel 386kb P20 GR - 05700574036638

SureFISH 20p13 Chr20pTel 386kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110848G
Not in Commercial Distribution

  • 05700574036638 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 19q13.43 Chr19qTel 405kb P20 GR - 05700574036621

SureFISH 19q13.43 Chr19qTel 405kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110847G
Not in Commercial Distribution

  • 05700574036621 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 19p13.3 Chr19pTel 409kb P20 GR - 05700574036614

SureFISH 19p13.3 Chr19pTel 409kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110846G
Not in Commercial Distribution

  • 05700574036614 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 18q23 Chr18qTel 413kb P20 GR - 05700574036607

SureFISH 18q23 Chr18qTel 413kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110845G
Not in Commercial Distribution

  • 05700574036607 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 18p11.32 Chr18pTel 403kb P20 GR - 05700574036591

SureFISH 18p11.32 Chr18pTel 403kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110844G
Not in Commercial Distribution

  • 05700574036591 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 17q25.3 Chr17qTel 405kb P20 GR - 05700574036584

SureFISH 17q25.3 Chr17qTel 405kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110843G
Not in Commercial Distribution

  • 05700574036584 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent

SureFISH 17p13.3 Chr17pTel 402kb P20 GR - 05700574036577

SureFISH 17p13.3 Chr17pTel 402kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110842G
Not in Commercial Distribution

  • 05700574036577 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
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