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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 Mycobacterium tuberculosis RPab - B502BSB29920

Mycobacterium tuberculosis 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

  • B502BSB29920 ()
BSB 2992

  • Mycobacterium tuberculosis immunoglobulin G (IgG) antibody IVD, reagent

Uroplakin III RPab - B502BSB22910

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB22910 ()
BSB 2291

  • Uroplakin IVD, antibody

Uroplakin III RPab - B502BSB22900

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB22900 ()
BSB 2290

  • Uroplakin IVD, antibody

Uroplakin III RPab - B502BSB22890

Uroplakin III is a purified immunoglobulin fraction of rabbit antiserum that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB22890 ()
BSB 2289

  • Uroplakin IVD, antibody

Tinto Uroplakin III RPab - B502BSB22880

Uroplakin III 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

  • B502BSB22880 ()
BSB 2288

  • Uroplakin IVD, antibody

Tinto Uroplakin III RPab - B502BSB22870

Uroplakin III 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

  • B502BSB22870 ()
BSB 2287

  • Uroplakin IVD, antibody

Tinto Uroplakin III RPab - B502BSB22860

Uroplakin III 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

  • B502BSB22860 ()
BSB 2286

  • Uroplakin IVD, antibody

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

NES Reprocessed Visions PV .014P RX Digital IVUS Catheter - NRP014

The device is the Philips Vision PV .014P RX Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-014R
Not in Commercial Distribution

  • NRP014 ()

  • Catheter Working Length: 150 Centimeter
  • Catheter Gauge: 3.5 French
  • Lumen/Inner Diameter: .014 Inch
R-014R

  • Intravascular ultrasound imaging catheter, reprocessed
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