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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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RX ACCULINK™ Carotid Stent System 6.0 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011338-40
In Commercial Distribution

  • 08717648076237 ()
1011338-40

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6.0 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011338-30
In Commercial Distribution

  • 08717648076220 ()
1011338-30

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 6.0 mm x 20 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011338-20
In Commercial Distribution

  • 08717648076213 ()
1011338-20

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 5.0 mm x 40 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-40
In Commercial Distribution

  • 08717648076206 ()
1011337-40

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 5.0 mm x 30 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-30
In Commercial Distribution

  • 08717648076190 ()
1011337-30

  • Bare-metal carotid artery stent
RX ACCULINK™ Carotid Stent System 5.0 mm x 20 mm x 132 cm Rapid-Exchange
ABBOTT VASCULAR INC.
1011337-20
In Commercial Distribution

  • 08717648076183 ()
1011337-20

  • Bare-metal carotid artery stent
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
37210
In Commercial Distribution

  • H628372101 ()
37210

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
C22846
In Commercial Distribution

  • 15099590701680 ()
C22846

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1414160-J
In Commercial Distribution

  • 00850007370435 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 160 Millimeter
TV-IL1414160-J

  • Abdominal aorta endovascular stent-graft
The Ovation iX™ Iliac Limbs are components of the Ovation Prime, Ovation iX, and Alto™ Abdominal Stent Graft Systems. The Ovation iX™ Iliac Limbs are comprised of a nitinol stent encapsulated in low-permeability PTFE. The iliac limbs are deployed into the leg sections of the aortic body. Additional iliac limbs may be used to extend the length of the device, where indicated.
Endologix, Inc.
TV-IL1414140-J
In Commercial Distribution

  • 00850007370220 ()

  • Stent Diameter: 14 Millimeter
  • Catheter Gauge: 60 French
  • Outer Diameter: 12 Femtometer
  • Lumen/Inner Diameter: 10 Femtometer
  • Stent Length: 140 Millimeter
TV-IL1414140-J

  • Abdominal aorta endovascular stent-graft
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