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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-IL1428140-J
In Commercial Distribution
- 00850007370091 ()
- Stent Diameter: 14 Millimeter
- Stent Diameter: 28 Millimeter
- Catheter Working Length: 60 Centimeter
- Outer Diameter: 15 Femtometer
- Lumen/Inner Diameter: 13 Femtometer
- Stent Length: 140 Millimeter
TV-IL1428140-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-IL1428160-J
In Commercial Distribution
- 00850007370008 ()
- Stent Diameter: 14 Millimeter
- Stent Diameter: 28 Millimeter
- Catheter Working Length: 60 Centimeter
- Outer Diameter: 15 Femtometer
- Lumen/Inner Diameter: 13 Femtometer
- Stent Length: 160 Millimeter
TV-IL1428160-J
- Abdominal aorta endovascular stent-graft
The Intellipac Reagent Module acts as a communication link with up to four reservoirs that house the test reagents as the Primer Extension Reaction is part of AvertD™, a prescription, qualitative genotyping test used to detect and identify 15 genetic polymorphisms in genomic DNA.
AUTOGENOMICS, INC
03-2560-01
In Commercial Distribution
- 10850009370201 ()
- 30850009370205 ()
03-2560-01
- Opioid use disorder (OUD) genotyping IVD, kit, nucleic acid technique (NAT)
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
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macrosteatosis less than or equal to 15%, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146
In Commercial Distribution
- 05060462240029 ()
- Liver donor-organ preservation/transport system
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0146_US
In Commercial Distribution
- 05060462240043 ()
- Liver donor-organ preservation/transport system
The OrganOx metra® is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
The OrganOx metra® device is suitable for liver grafts from donors after brain death (DBD), or liver grafts from donors after circulatory death (DCD) less than or equal to 40 years old, with less than or equal to 20 mins of functional warm ischemic time (time from donor systolic blood pressure less than 50 mmHg), and macro steatosis less than or equal to 15 percent, in a near-physiologic, normothermic and functioning state intended for a potential transplant recipient.
ORGANOX LIMITED
D0003
In Commercial Distribution
- 05060462240005 ()
- Liver donor-organ preservation/transport system
System Controller Low Flow 2.0
Thoratec Corporation
106531LF2
In Commercial Distribution
- 05415067031105 ()
106531LF2
- Implantable ventricular circulatory assist system control unit
Outflow Graft Clip
Thoratec Corporation
10012390GBL
In Commercial Distribution
- 05415067030269 ()
10012390GBL
- Implantable ventricular circulatory assist system
Wireless Adapter
Thoratec Corporation
HMT2100
In Commercial Distribution
- 05415067032065 ()
HMT2100
- Medical networking interface unit