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Patient-specific, full-face 3D printed anatomic model depicting a patient’s treatment plan. Non-diagnostic. RX only.
Mirrorme3d, LLC
FFS
In Commercial Distribution
- 00860008704146 ()
- Custom-made organ/bone anatomy model
Patient-specific, full-face 3D printed anatomic model depicting a patient’s baseline or preoperative status. Non-diagnostic. Rx only.
Mirrorme3d, LLC
FFB
In Commercial Distribution
- 00860008704139 ()
- Custom-made organ/bone anatomy model
OxiWear Device and Charger Bundle - Medical - Package of 1
OXIWEAR, INC.
OxiV3
In Commercial Distribution
- 00860008683236 ()
- 10860008683233 ()
- 20860008683230 ()
M-001-01
- Wearable multiple physiological parameter recorder, reusable
Endovaginal Probe 3D
Halo Medical Technologies, LLC
HMT-EVG 3D
In Commercial Distribution
- 00860008657374 ()
- Rectal/vaginal ultrasound imaging transducer
Endovaginal Probe 2D
Halo Medical Technologies, LLC
HMT-EVG
In Commercial Distribution
- 00860008657367 ()
- Rectal/vaginal ultrasound imaging transducer
Midcrystal Probe 3D
Halo Medical Technologies, LLC
HMT-MCP 3D
In Commercial Distribution
- 00860008657350 ()
- Rectal/vaginal ultrasound imaging transducer
MidCrystal Probe 2D
Halo Medical Technologies, LLC
HMT-MCP
In Commercial Distribution
- 00860008657343 ()
- Rectal/vaginal ultrasound imaging transducer
Transrectal Probe 3D
Halo Medical Technologies, LLC
HMT-TRP 3D
In Commercial Distribution
- 00860008657336 ()
- Rectal/vaginal ultrasound imaging transducer
Transrectal Probe 2D
Halo Medical Technologies, LLC
HMT-TRP
In Commercial Distribution
- 00860008657329 ()
- Rectal/vaginal ultrasound imaging transducer
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)