Duns Number:078473721
Device Description: The Cassi Rotational Core Biopsy System is used to perform biopsy procedureson multiple pa 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
Catalog Number
-
Brand Name
Cassi
Version/Model Number
CS2100-NT-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
Yes
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
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
d9899999-8a87-406f-82a6-bf7dd7e5edc6
Public Version Date
March 08, 2021
Public Version Number
4
DI Record Publish Date
September 30, 2016
Package DI Number
10866479000128
Quantity per Package
10
Contains DI Package
00866479000121
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |