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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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Alexis Wound Protector-Retractor - 00607915132958

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8322
In Commercial Distribution

  • 10607915132955 ()
  • 00607915132958 ()

  • 2-4 cm


  • Radial surgical retractor

Alexis Wound Protector-Retractor - 00607915117245

Wound Retractor and Protector
APPLIED MEDICAL RESOURCES CORPORATION
C8312
In Commercial Distribution

  • 10607915117242 ()
  • 00607915117245 ()

  • 2-4 cm


  • Radial surgical retractor

MONOFLUO - 00847865001519

MONOFLUO Pneumocystis jirovecii (P. carinii) IFA Test
Bio-RAD Laboratories, Inc.
32515
In Commercial Distribution

  • 00847865001519 ()

  • 24 Tests
32515

  • Pneumocystis jirovecii antigen IVD, kit, direct fluorescent test (DFT)

Kallestad - 00847865001496

MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay

RINGLOC + INSTRUMENTATION - 05019279415328

No Description
Biomet Uk Ltd
31-400624
In Commercial Distribution

  • 05019279415328 ()

  • SIZE 24
31-400624

  • Orthopaedic implant impactor, reusable

GenetiSure Dx Hybridization Kit - 05700571112625

GenetiSure Dx Hybridization Kit
AGILENT TECHNOLOGIES, INC.
K1201-64200
In Commercial Distribution

  • 05700571112625 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Labeling Kit Purification Columns - 05700571112618

GenetiSure Dx Labeling Kit Purification Columns
AGILENT TECHNOLOGIES, INC.
K1201-64110
In Commercial Distribution

  • 05700571112618 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Labeling Kit - 05700571112601

GenetiSure Dx Labeling Kit
AGILENT TECHNOLOGIES, INC.
K1201-64105
In Commercial Distribution

  • 05700571112601 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

GenetiSure Dx Postnatal Assay - 05700571108697

GenetiSure Dx Postnatal Assay
AGILENT TECHNOLOGIES, INC.
K1201A
In Commercial Distribution

  • 05700571108697 ()

  • 24 tests


  • Intellectual/developmental disability genotyping IVD, kit, nucleic acid technique (NAT)

Sierra™ - 10889910059141

S2S CrossBar, 24 - 29mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile
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