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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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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
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
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
BandLok is intended for use as a chemical cure band cement. This is the 6 gm syringe of Part B.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSB
In Commercial Distribution

  • D798BLSB0 ()
BLSB

  • Orthodontic bracket adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126 B
In Commercial Distribution

  • D801SP65126B1 ()
65-126

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Activator / Primer Plastic Bottle. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-126
In Commercial Distribution

  • D801SP651261 ()
65-126

  • Dentine adhesive
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
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 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 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
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