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LOADING SYS L-EVOLUTFX-34
MEDTRONIC COREVALVE LLC
L-EVOLUTFX-34
In Commercial Distribution
- 00763000942731 ()
- 34 MM
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
LOADING SYS L-EVOLUTFX-2329
MEDTRONIC COREVALVE LLC
L-EVOLUTFX-2329
In Commercial Distribution
- 00763000942724 ()
- 2329 MM
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
DELIV SYS D-EVOLUTFX-34
MEDTRONIC COREVALVE LLC
D-EVOLUTFX-34
In Commercial Distribution
- 00763000942717 ()
- 34 MM
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
DELIV SYS D-EVOLUTFX-2329
MEDTRONIC COREVALVE LLC
D-EVOLUTFX-2329
In Commercial Distribution
- 00763000942700 ()
- 2329 MM
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
SAPIEN 3 Ultra valve with Commander delivery System
Edwards Lifesciences LLC
9750CM23
In Commercial Distribution
- 00690103207828 ()
- Outer Diameter: 23.0000 Millimeter
9750CM23A
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
- Mitral transcatheter heart valve bioprosthesis
Commander DS with SAPIEN 3 Ultra Loader
Edwards Lifesciences LLC
9750CM29
In Commercial Distribution
- 00690103217001 ()
- Outer Diameter: 29 Millimeter
9750CM29A
- Catheter/overtube balloon inflator, single-use
The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results.
The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner.
Otsuka America Pharmaceutical Inc
01
In Commercial Distribution
- 00857335005008 ()
- 10857335005029 ()
- Helicobacter pylori urease IVD, kit, chromogenic
The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer.
The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations.
FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment.
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228034223 ()
873121
- PIK3CA gene mutation IVD, kit, nucleic acid technique (NAT)
The Model 2740C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-018-001
In Commercial Distribution
- 00855728005994 ()
2740C
- Implantable sleep apnoea treatment system, respiration-sensing
Kit for single use during a Neuro treatment guided under 1.5T MRI guidance.
Kit content:
Part Description
ASC002258-AA BRAIN COIL 1.5T ASSY
MPR000444 HEAD RING SCREWS LONG
SET000932 INSIGHTEC NEURO DQA PHANTOM GEL SET
SET000933 EXABLATE NEURO CLEANING KIT
SET400187 NEURO TREATMENT ACCESSORIES KIT
INSIGHTEC LTD
Neuro Kit 1.5T for USA
In Commercial Distribution
- 07290015461146 ()
SET000937
- Therapeutic oncological/gynaecological ultrasound system