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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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CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR PROMAG WITH COAXIAL NEEDLE, 18G X 120MM, PINK
CUSTOMED INC
712057831812
In Commercial Distribution

  • M20890010918120 ()
  • M20890010918121 ()

  • Length: 120 Millimeter
  • Needle Gauge: 18 Gauge
9001091812

  • Soft-tissue biopsy needle, single-use
CUSTOMED UNIVERSAL-D BIOPSY NEEDLE FOR BARD MAGNUM WITH COAXIAL NEEDLE, 18G X 160MM, PINK
CUSTOMED INC
712057831816
In Commercial Distribution

  • M20890009918160 ()
  • M20890009918161 ()

  • Length: 160 Millimeter
  • Needle Gauge: 18 Gauge
9000991816

  • Soft-tissue biopsy needle, single-use
The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5489
In Commercial Distribution

  • 00613745054896 ()

  • 100 tests
5489

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5425
In Commercial Distribution

  • 00613745054254 ()

  • 25 tests
5425

  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, multiplex
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5189
In Commercial Distribution

  • 00613745051895 ()

  • 100 tests
5189

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories.
Genbio
800-5125
In Commercial Distribution

  • 00613745051253 ()

  • 25 tests
5125

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex
Rheumatoid Factor Total is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class rheumatoid factor in human serum or plasma. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis, in conjunction with other laboratory and clinical findings.
ORGENTEC Diagnostika GmbH
ORG522T
Not in Commercial Distribution

  • 04260157080263 ()
ORG522T

  • Proteinase 3 anti-neutrophil cytoplasmic antibody (PR3-ANCA) IVD, kit, multiplex
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-3X3
In Commercial Distribution

  • 00854258006099 ()

  • Width: 7.5 Centimeter
  • Length: 7.5 Centimeter


  • Bioabsorbable wound dressing
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-2X2
In Commercial Distribution

  • 00854258006082 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Bioabsorbable wound dressing
The Restrata™ Wound Matrix is a sterile, single use device intended for use in local management of wounds. The Restrata™ Wound Matrix is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body’s natural healing process to occur.
Acera Surgical Inc
RWM1-1X3
In Commercial Distribution

  • 00854258006075 ()

  • Length: 7.5 Centimeter
  • Width: 2.5 Centimeter


  • Bioabsorbable wound dressing
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