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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Ultrasonic Scalpel Shears with Advanced Hemostasis
STRYKER SUSTAINABILITY SOLUTIONS, INC.
HAR1136
In Commercial Distribution

  • 57613327586584 ()
  • 07613327586589 ()

  • Diameter: 5.0 Millimeter
  • Length: 36.0 Centimeter
HAR1136

  • Soft-tissue ultrasonic surgical system holder/tip, reprocessed
Ultrasonic Scalpel Shears with Advanced Hemostasis
STRYKER SUSTAINABILITY SOLUTIONS, INC.
HAR1120
In Commercial Distribution

  • 57613327586560 ()
  • 07613327586565 ()

  • Diameter: 5.0 Millimeter
  • Length: 20.0 Centimeter
HAR1120

  • Soft-tissue ultrasonic surgical system holder/tip, reprocessed
allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
ALLWIN MEDICAL DEVICES, INC.
allSoft Urinary Diversion Stents [Mono - J] Open Tip 5F, 70cm
In Commercial Distribution

  • 10812261011810 ()
  • 00812261011813 ()
MJO-5/70

  • Polymeric ureteral stent
Temporary Locking Extended Tab Driver
ALPHATEC SPINE, INC.
CI-10591
In Commercial Distribution

  • 00811801039966 ()


  • Surgical instrument handle, torque-limiting
For use in the detection of biotinylated proteins and nucleic acids in biotinylated proteins and nucleic acids in LABType™ SSO TYPING TESTS and LABType XR and CWD DNA Typing Test assays.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117015484 ()
LSPSAB2

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117014654 ()
LS2AEX01

  • HLA class I & II antibody screening IVD, kit, multiplex
LABScreen products are intended for use in detection of HLA antibody using flow cytometric technology
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117010199 ()
LS1AEX01

  • HLA class I & II antibody screening IVD, kit, multiplex
ARK™ Methotrexate II Dilution Buffer is intended for dilution of specimens containing high concentrations of methotrexate for the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0004-00
In Commercial Distribution

  • 00812101031223 ()
5071-0004-00

  • Methotrexate therapeutic drug monitoring IVD, calibrator
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-02
In Commercial Distribution

  • 00812101031216 ()
5071-0003-02

  • Methotrexate therapeutic drug monitoring IVD, control
ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II Assay.
ARK DIAGNOSTICS INC
5071-0003-01
In Commercial Distribution

  • 00812101031209 ()
5071-0003-01

  • Methotrexate therapeutic drug monitoring IVD, control
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