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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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45mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD5
In Commercial Distribution

  • 1111095 ()
  • M364111109FD50 ()

  • Outer Diameter: 9 Millimeter
  • Length: 45 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
40mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD4
In Commercial Distribution

  • 1111094 ()
  • M364111109FD40 ()

  • Outer Diameter: 9 Millimeter
  • Length: 40 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
35mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD3
In Commercial Distribution

  • 1111093 ()
  • M364111109FD30 ()

  • Outer Diameter: 9 Millimeter
  • Length: 35 Millimeter


  • Sacroiliac joint intra-articular arthrodesis implant
30mm SAMBA Screw; The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
MEDICAL DESIGNS LLC
11-1109-FD2
In Commercial Distribution

  • M364111109FD20 ()
  • 1111092 ()

  • Length: 30 Millimeter
  • Outer Diameter: 9 Millimeter
11-1109-FD2

  • Sacroiliac joint intra-articular arthrodesis implant
Tinto HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
BIO SB, INC.
BSB 2037 (ASR)
In Commercial Distribution

  • B502BSB2037ASR0 ()

  • Total Volume: 15 Milliliter
BSB 2037 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
BIO SB, INC.
BSB 2036 (ASR)
In Commercial Distribution

  • B502BSB2036ASR0 ()

  • Total Volume: 7 Milliliter
BSB 2036 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto HER-2 neu is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
BIO SB, INC.
BSB 2035 (ASR)
In Commercial Distribution

  • B502BSB2035ASR0 ()

  • Total Volume: 3 Milliliter
BSB 2035 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Progesterone Receptor is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
BIO SB, INC.
BSB 2575 (ASR)
In Commercial Distribution

  • B502BSB2575ASR0 ()

  • Total Volume: 15 Milliliter
BSB 2575 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Progesterone Receptor is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
BIO SB, INC.
BSB 2574 (ASR)
In Commercial Distribution

  • B502BSB2574ASR0 ()

  • Total Volume: 7 Milliliter
BSB 2574 (ASR)

  • Assay development analyte-specific reagent IVD
Tinto Progesterone Receptor is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5 (analyte specific reagent)
BIO SB, INC.
BSB 2573 (ASR)
In Commercial Distribution

  • B502BSB2573ASR0 ()

  • Total Volume: 3 Milliliter
BSB 2573 (ASR)

  • Assay development analyte-specific reagent IVD
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