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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 Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in: 1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Beckman Coulter, Inc.
33211
In Commercial Distribution

  • H628332111 ()
33211

  • Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassay
Occluder, Internal Vessel, Temporary
GENZYME CORPORATION
LG100
Not in Commercial Distribution

  • 20358468019039 ()

  • Total Volume: 1 Milliliter
  • one 1.0 mL syringe with three cannulae (1.0 x 40 mm, 1.5 x 40 mm and 3.0 x 80 mm)


  • Intravascular occluding solution kit
Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals; re-manufactured, (unpackaged unit).
CARDIOCOMMAND, INC.
Re-manufactured, unpackaged
In Commercial Distribution

  • 00856233005196 ()
0104-9999

  • Electrocardiographic signal amplifier
Amplification and signal processing module designed to interface with CardioCommand esophageal catheters to enable recording of esophageal cardiac signals, (single unit package).
CARDIOCOMMAND, INC.
Single pack
In Commercial Distribution

  • 10856233005186 ()
0104

  • Electrocardiographic signal amplifier
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696687 ()

  • Diopter 28
CZ70BD.280

  • Posterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696670 ()

  • Diopter 27.5
CZ70BD.275

  • Posterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696663 ()

  • Diopter 27
CZ70BD.270

  • Posterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696656 ()

  • Diopter 26.5
CZ70BD.265

  • Posterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696649 ()

  • Diopter 26
CZ70BD.260

  • Posterior-chamber intraocular lens, pseudophakic
SINGLE-PIECE PMMA STERILE PCL (IOL/PC),12.5mm LENGTH, 7.0mm BICONVEX OPTIC,5-DEGREE "SLANT"(TM*) HAPTICS WITH EYELETS. *REG. U.S. PAT. & TM OFF.
Alcon Laboratories, Inc.
CZ70BD
In Commercial Distribution

  • 00380650696632 ()

  • Diopter 25.5
CZ70BD.255

  • Posterior-chamber intraocular lens, pseudophakic
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