SCION MEDICAL TECHOLOGIES, LLC

GUDID#

BEACON - 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.
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
BEACON - 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.
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
Cassi - 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
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
Cassi - 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
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
Cassi - 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
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
Cassi - 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
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
BEACON - 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.
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
Cassi - The Cassi Rotational Core Biopsy System is used to perform biopsy procedures on 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 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30
Cassi - The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (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 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
2016-09-30