Cassi

Primary DI
00866479000138
Brand
Cassi
Company
SCION MEDICAL TECHOLOGIES, LLC
Model
CS2120-NT-1
Device description
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
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866479000135PackageGS110In Commercial Distribution
00866479000138PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086647900013510866479000135
00866479000138008664790001388664790001380866479000138

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). This is a single-use device.

Regulatory Flags#

DUNS number
078473721
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866479000114BEACONBM1412-50-F-12016-09-30
00866479000107BEACONBM1412-50-12016-09-30
00866479000121CassiCS2100-NT-12016-09-30
00866479000145CassiCS2001-BH2016-09-30
00866479000152CassiCS-2001-CC-102016-09-30
30866479000115BEACONBM1412-50-F-12016-09-30
10866479000128CassiCS2100-NT-12016-09-30
10866479000135CassiCS2120-NT-12016-09-30

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Primary DI, Brand, Company table
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