SCION MEDICAL TECHOLOGIES, LLC

Address:225 South Main Street,Kyle,TX,78640,US

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Device Description : Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) aswell as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. Beacon Tissue Marker/Beacon Tissue Marker (SE) is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. Beacon Tissue Marker/Beacon Tissue Marker (SE) is supplied pre-loaded in the delivery device. The Beacon Tissue Marker delivery device has a beveled 12cm/14G needle with 1cm depth marks and a plunger. The Beacon Tissue Marker (SE) delivery device has a radiused tip 12cm/14G cannula with 1cm depth marks anda plunger.

Device Class :

Duns Number: 078473721

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, Beacon Tissue Marker/Beacon Tissue Marker (SE) is a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) aswell as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength. Beacon Tissue Marker/Beacon Tissue Marker (SE) is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.Beacon Tissue Marker/Beacon Tissue Marker (SE) is supplied pre-loaded in the delivery device.The Beacon Tissue Marker delivery device has a beveled 12cm/14G needle with 1cm depth marks and a plunger. The Beacon Tissue Marker (SE) delivery device has a radiused tip 12cm/14G cannula with 1cm depth marks anda plunger.

Device Class : 2

Duns Number: 078473721

Premarket Exempt : No

Product Code : NEU

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Cassi Rotational Core Biopsy System is used to perform biopsy procedureson m The Cassi Rotational Core Biopsy System is used to perform biopsy procedureson multiple patients. Up to 7 biopsy cycles (1 mandatory pre-testand 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are:REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge10 – Sterile single-use biopsy needles and sample trays; comprisedof a 19 gauge x 2 cm length securing needle with 10 gauge cuttingcannula with trocarREF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge10 – Sterile single-use biopsy needles and sample trays; comprised ofa 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannulawith trocarREF: CS2001-CC-1010 – Non-sterile single-use CO2 (carbon dioxide) canisters with capsREF:CS2001-BH1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use9 – volt alkaline battery

Device Class : 2

Duns Number: 078473721

Premarket Exempt : No

Product Code : KNW

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perf The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perform biopsy pro-cedures on multiple patients. Up to 7 biopsycycles (1 mandatory pre-test and 6 biopsies) can be performed per patient.The Cassi system components and catalog numbers are:REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge10 – Sterile single-use biopsy needles and sample trays; comprisedof a 19 gauge x 2 cm length securing needle with 10 gauge cuttingcannula with trocarREF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge10 – Sterile single-use biopsy needles and sample trays; comprised ofa 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannulawith trocarREF: CS2001-CC-1010 – Non-sterile single-use CO2 (carbon dioxide) canisters with capsREF:CS2001-BH1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use9 – volt alkaline battery

Device Class : 2

Duns Number: 078473721

Premarket Exempt : No

Product Code : KNW

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perf The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perform biopsy pro-cedures on multiple patients. Up to 7 biopsycycles (1 mandatory pre-test and 6 biopsies) can be performed per patient.The Cassi system components and catalog numbers are:REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge10 – Sterile single-use biopsy needles and sample trays; comprisedof a 19 gauge x 2 cm length securing needle with 10 gauge cuttingcannula with trocarREF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge10 – Sterile single-use biopsy needles and sample trays; comprised ofa 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannulawith trocarREF: CS2001-CC-1010 – Non-sterile single-use CO2 (carbon dioxide) canisters with capsREF:CS2001-BH1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use9 – volt alkaline battery

Device Class : 2

Duns Number: 078473721

Premarket Exempt : No

Product Code : KNW

Prescription Use : No

Device Count : 1

- Catalog Number :

Device Description : The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perf The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perform biopsy pro-cedures on multiple patients. Up to 7 biopsycycles (1 mandatory pre-test and 6 biopsies) can be performed per patient.The Cassi system components and catalog numbers are:REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge10 – Sterile single-use biopsy needles and sample trays; comprisedof a 19 gauge x 2 cm length securing needle with 10 gauge cuttingcannula with trocarREF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge10 – Sterile single-use biopsy needles and sample trays; comprised ofa 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannulawith trocarREF: CS2001-CC-1010 – Non-sterile single-use CO2 (carbon dioxide) canisters with capsREF:CS2001-BH1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use9 – volt alkaline battery

Device Class : 2

Duns Number: 078473721

Premarket Exempt : No

Product Code : KNW

Prescription Use : No

Device Count : 1