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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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No Description
BIOMET SPINE LLC
1200-3018
In Commercial Distribution

  • 00880304975170 ()

  • ALTIUS OCCIPITAL BONE SCREW 5.0MM (D) X 18MM (L)
1200-3018

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
1200-3019
In Commercial Distribution

  • 00880304975163 ()

  • ALTIUS OCCIPITAL BONE SCREW 5.0MM (D) X 19MM (L)
1200-3019

  • Bone-screw internal spinal fixation system, non-sterile
No Description
BIOMET SPINE LLC
1200-3020
In Commercial Distribution

  • 00880304975156 ()

  • ALTIUS OCCIPITAL BONE SCREW 5.0MM (D) X 20MM (L)
1200-3020

  • Bone-screw internal spinal fixation system, non-sterile
Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, and Nitrite in Urine.
GERMAINE LABORATORIES, INC
59100
In Commercial Distribution

  • 00695684591007 ()
  • 00695684591001 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
No Description
GERMAINE LABORATORIES, INC
51111
In Commercial Distribution

  • 00695684511111 ()
  • 00695684511112 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Vitamin C (ascorbic acid) IVD, reagent
Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine.
GERMAINE LABORATORIES, INC
51100
In Commercial Distribution

  • 00695684511005 ()
  • 00695684511012 ()


  • Urine leukocyte IVD, kit, rapid colorimetric, clinical
  • Urine nitrite IVD, kit, rapid colorimetric, clinical
  • Urine urobilinogen IVD, kit, rapid colorimetric, clinical
  • Urine protein IVD, kit, rapid colorimetric, clinical
  • Urine pH IVD, kit, rapid colorimetric, clinical
  • Urine blood IVD, kit, rapid colorimetric, clinical
  • Urine specific gravity IVD, kit, rapid colorimetric, clinical
  • Urine ketone IVD, kit, rapid colorimetric, clinical
  • Urine bilirubin IVD, kit, rapid colorimetric, clinical
  • Urine glucose IVD, kit, rapid colorimetric, clinical
  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
Biomet Orthopedics, LLC
456407
In Commercial Distribution

  • 00880304378940 ()
456407

  • Surgical drill guide, reusable
Mission Urinalysis Reagent Strips (ASC/GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
Acon Laboratories, Inc.
U031-111
In Commercial Distribution

  • 20682607200416 ()
  • 00682607200412 ()
  • 00682607001040 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT/LEU)
Acon Laboratories, Inc.
U031-101
In Commercial Distribution

  • 20682607200409 ()
  • 00682607200405 ()
  • 00682607001033 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Mission Urinalysis Reagent Strips (GLU/BIL/KET/SG/BLO/PH/PRO/URO/NIT)
Acon Laboratories, Inc.
U031-091
In Commercial Distribution

  • 20682607200393 ()
  • 00682607200399 ()
  • 00682607001026 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
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