Cassi - The Cassi Rotational Core Biopsy System with - SCION MEDICAL TECHOLOGIES, LLC

Duns Number:078473721

Device Description: The Cassi Rotational Core Biopsy System with Quadpoint Disposable isused to perform biopsy 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

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More Product Details

Catalog Number

-

Brand Name

Cassi

Version/Model Number

CS-2001-CC-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KNW

Product Code Name

Instrument, Biopsy

Device Record Status

Public Device Record Key

516b084b-4c2d-4f76-953e-ca8273f90435

Public Version Date

March 08, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCION MEDICAL TECHOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5