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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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FUJIFILM IRVINE SCIENTIFIC, INC.
91005-100ML
In Commercial Distribution

  • 00893727002408 ()

  • Total Volume: 100 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-100ML
In Commercial Distribution

  • 00893727002392 ()

  • Total Volume: 100 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-20X5mL
In Commercial Distribution

  • 00893727002217 ()
  • 10893727002214 ()

  • Total Volume: 5 Milliliter
90128

  • IVF medium
Freezing Medium With Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
90128-100mL
In Commercial Distribution

  • 00893727002200 ()

  • Total Volume: 100 Milliliter
90128

  • IVF medium
Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)
TELEFLEX INCORPORATED
IPN920367
In Commercial Distribution

  • 20801902194101 ()
  • 10801902194104 ()
PT-65709-W

  • Thrombectomy rotational catheter
Arrow-Trerotola(TM) Over-The-Wire PTD(R) Kit (Percutaneous Thrombolytic Device)
TELEFLEX INCORPORATED
IPN920366
In Commercial Distribution

  • 20801902194095 ()
  • 10801902194098 ()
PT-65709-HFWC

  • Thrombectomy rotational catheter
Arrow-Trerotola(TM) PTD(R) Kit (Percutaneous Thrombolytic Device)
TELEFLEX INCORPORATED
IPN920365
In Commercial Distribution

  • 20801902194088 ()
  • 10801902194081 ()
PT-65509-HFC

  • Thrombectomy rotational catheter
Arrow-Trerotola(TM) PTD(R)* Rotator Drive Unit
TELEFLEX INCORPORATED
IPN920361
In Commercial Distribution

  • 20801902194040 ()
  • 10801902194043 ()
PT-03000-R

  • Thrombectomy rotational catheter
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
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
Not in Commercial Distribution

  • 08600105181752 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
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