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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
The Model 2740S&C 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.
900-026-001
In Commercial Distribution
- 00810098650311 ()
2740S&C
- 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
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 1.5cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K1
In Commercial Distribution
- M2138063M0K15 ()
- Total Volume: 1.5 Milliliter
- Dermal tissue reconstructive material, microbe-derived, anaesthetic
Radiesse Injectable Implant is a volumizing filler intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles.
MERZ NORTH AMERICA, INC.
8071M0H1
In Commercial Distribution
- M2138071M0H15 ()
- Total Volume: 1.5 Milliliter
- Dermal tissue reconstructive material, synthetic mineral
The Refill Kit is sterile and provides the components and instructions necessary to access the pump reservoir to empty and fill the Prometra Programmable Pump. The drug chamber is refillable and is percutaneously accessed via the centrally-located access port using a 22-gauge non-coring needle.
Flowonix Medical, Inc.
11825
In Commercial Distribution
- 00810335020143 ()
- General surgical procedure kit, non-medicated, single-use
Kit for single use during a Neuro treatment guided under 3T MRI guidance.
Kit content:
Part Description
ASM000355 PATIENT MEMBRANE PACKING 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 3T for USA
In Commercial Distribution
- 07290015461122 ()
SET000936
- Therapeutic oncological/gynaecological ultrasound system
Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8063M0K2
In Commercial Distribution
- M2138063M0K25 ()
- M2138063M0K22 ()
- Total Volume: 3.0 Milliliter
- Dermal tissue reconstructive material, microbe-derived, anaesthetic
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)
Zilver 518RX Vascular Stent, Rapid Exchange Self-Expanding Stent
COOK IRELAND LTD
G49333
Not in Commercial Distribution
- 10827002493336 ()
ZIVX5-18-125-10-80
- Peripheral artery stent, bare-metal