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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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Tinto Myoglobin, RPab - B502BSB58000

Tinto Myoglobin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB58000 ()
BSB 5800

  • Myoglobin IVD, antibody

Tinto Myoglobin, RPab - B502BSB57990

Tinto Myoglobin is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB57990 ()
BSB 5799

  • Myoglobin IVD, antibody

Tinto Lysozyme, RPab - B502BSB57300

Tinto Lysozyme is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB57300 ()
BSB 5730

  • Lysozyme (muramidase) IVD, antibody

Tinto hPL, RPab - B502BSB68020

Tinto hPL is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • B502BSB68020 ()
BSB 6802

  • Human placental lactogen (HPL) IVD, antibody

Tinto hPL,RPab - B502BSB68010

Tinto hPL is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB68010 ()
BSB 6801

  • Human placental lactogen (HPL) IVD, antibody

Tinto hPL, RPab - B502BSB68000

Tinto hPL is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 3 ml
In Commercial Distribution

  • B502BSB68000 ()
BSB 6800

  • Human placental lactogen (HPL) IVD, antibody

Microlife - 00810445030001

MedGem is an indirect calorimeter, which is intended to measure oxygen uptake for measurement of patient resting metabolic rate (RMR).
MICROLIFE USA, INC.
MedGem
In Commercial Distribution

  • 00810445030001 ()


  • Indirect calorimeter

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - B227NRP1300

The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)
NORTH EAST SCIENTIFIC INC
R-410-154
In Commercial Distribution

  • B227NRP1300 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: 0.014 Inch
  • Guidewire Compatibility: 4 French
R-410-154

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368

The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter - NRP130

The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-154
Not in Commercial Distribution

  • NRP130 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French


  • Atherectomy laser system beam guide-catheter, peripheral
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