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Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector
RESPICARDIA, INC.
3602
In Commercial Distribution
- 00857688007438 ()
- Transvenous phrenic nerve electrical stimulation control unit
Lead Test Adaptor, remede EL-X, for use with Inline Connector Leads
RESPICARDIA, INC.
1007
In Commercial Distribution
- 00857688007421 ()
- Transvenous phrenic nerve electrical stimulation control unit
remede EL/EL-X external pulse generator
RESPICARDIA, INC.
1006A
In Commercial Distribution
- 00857688007414 ()
- Transvenous phrenic nerve electrical stimulation control unit
remede EL-X System, implantable pulse generator for phrenic nerve stimulation, inline connector header
RESPICARDIA, INC.
1600
In Commercial Distribution
- 00857688007407 ()
- Transvenous phrenic nerve electrical stimulation control unit
remede EL System, implantable pulse generator for phrenic nerve stimulation, IS-1 header
RESPICARDIA, INC.
1100
In Commercial Distribution
- 00857688007391 ()
- Transvenous phrenic nerve electrical stimulation control unit
The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure.
Pramand LLC
SS-2055
In Commercial Distribution
- 20860010683723 ()
- 00860010683729 ()
SS-2055
- Dura mater sealant
The DETOUR System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.
PQ Bypass, Inc.
ENDOCROSS
In Commercial Distribution
- 00860008946409 ()
ENDOCROSS
- Vascular guide-catheter, single-use
MI Cancer Seek is a next-generation sequencing (NGS) based in vitro diagnostic (IVD) device using total nucleic acid (TNA) isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens for the detection of single nucleotide variants (SNVs) and insertions and deletions (indels) in 228 genes, microsatellite instability (MSI) tumor
mutational burden (TMB) in patients with previously diagnosed solid tumors, and copy number amplification (CNA) in one gene in patients with breast cancer. MI Cancer Seek is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the approved therapeutic product labeling. Additionally, MI Cancer Seek is intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms. Genomic findings other than those listed as companion diagnostic indications are not prescriptive or conclusive for labeled use of any specific therapeutic product.
CARIS MPI, INC.
MCS000
In Commercial Distribution
- 00860008613325 ()
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Sterilization Tray
Lumicell, Inc.
900-00209
In Commercial Distribution
- 00860008537898 ()
- Device sterilization/disinfection container, reusable
Programmer
EBR Systems, Inc.
5100
In Commercial Distribution
- 00859244007296 ()
- Cardiac pulse generator programmer