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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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5mm 0 Degree 45cm HD Laparoscope, Autoclavable, Made in Germany, Wide Angle View with Blue Eye Piece
Surgical Direct, Inc.
SD805-0045
In Commercial Distribution

  • B382SD80500450 ()
SD805-0045

  • Rigid video laparoscope
CAPTURE™ Cannulated Screw System The ratchet handle is used in conjunction with the Digital Fusion screws.
Ascension Orthopedics, Inc.
AD-1007
In Commercial Distribution

  • M269AD10071 ()
  • 10381780241683 ()
AD1007

  • Surgical instrument handle, non-torque-limiting
Cadence Talar Cut Guide is used in making a precise cut of the Talus bone during resectioning.
Ascension Orthopedics, Inc.
10203026
Not in Commercial Distribution

  • M268102030261 ()
  • 10381780240242 ()

  • Large


  • Custom-made orthopaedic/craniofacial surgical guide
Cadence Talar Cut Guide is used in making a precise cut of the Talus bone during resectioning.
Ascension Orthopedics, Inc.
10203025
Not in Commercial Distribution

  • M268102030251 ()
  • 10381780240235 ()

  • Small


  • Custom-made orthopaedic/craniofacial surgical guide
Integra® Ti6® The removal driver shaft is used in conjunction with the Ti6 TH-series screws.
Ascension Orthopedics, Inc.
FS4040
In Commercial Distribution

  • M269FS40401 ()
  • 10381780245216 ()

  • 65mm L x 2.67mm Diameter
FS4040

  • Orthopaedic inorganic implant inserter/extractor, reusable
7-core HPV Cervical Cancer Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB02940 ()
BSB 0294

  • Biological stain control IVD
Anti-Mouse/Rabbit Immunoglobulin conjugated to Horseradish Peroxidase used in Mouse/Rabbit PolyDetector DAB HRP Brown Detection System.
BIO SB, INC.
Ready-to-use, 200 ml each
In Commercial Distribution

  • B502BSB0207H0 ()
BSB 0207H

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Anti-Mouse/Rabbit Immunoglobulin conjugated to Horseradish Peroxidase used in Mouse/Rabbit PolyDetector DAB HRP Brown Detection System.
BIO SB, INC.
Ready-to-use, 1000 ml
In Commercial Distribution

  • B502BSB0207AH0 ()
BSB 0207AH

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Anti-Mouse/Rabbit Immunoglobulin conjugated to Horseradish Peroxidase used in Mouse/Rabbit PolyDetector DAB HRP Brown Detection System.
BIO SB, INC.
Ready-to-use, 100 ml each
In Commercial Distribution

  • B502BSB0205H0 ()
BSB 0205H

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Anti-Mouse/Rabbit Immunoglobulin conjugated to Horseradish Peroxidase used in Mouse/Rabbit PolyDetector DAB HRP Brown Detection System.
BIO SB, INC.
Ready-to-use, 50 ml each
In Commercial Distribution

  • B502BSB0203H0 ()
BSB 0203H

  • Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
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