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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23kHz Extended Length Laparoscopic Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7404LSEA
In Commercial Distribution

  • 10381780533887 ()
C7404LSEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA Clarity 23kHz Standard Laparoscopic Tip (Five Pack)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7404S
In Commercial Distribution

  • 30381780533874 ()
  • 10381780533870 ()
C7404S

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
23kHz Standard Length Laparoscopic Tip
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7404SEA
In Commercial Distribution

  • 10381780533863 ()
C7404SEA

  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA Clarity 23kHz Expanded CEM Nosecone (5 Pack)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7523X
In Commercial Distribution

  • 30381780536387 ()
  • 10381780536383 ()
C7523X

  • Ultrasonic surgical system adaptor, single-use
CUSA Clarity 23kHz Single-Sided Bone Tip (Five Pack)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7421S
In Commercial Distribution

  • 30381780536363 ()
  • 10381780536369 ()
C7421S

  • Hard-tissue ultrasonic surgical system handpiece tip
CUSA Clarity 23kHz Single-Sided Bone Tip (Single Pack)
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7421SEA
In Commercial Distribution

  • 10381780536352 ()
C7421SEA

  • Hard-tissue ultrasonic surgical system handpiece tip
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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