Cassi
Basic Information
- Brand Name
- Cassi
- Primary DI
- 00866479000152
- Version / Model
- CS-2001-CC-10
- Company Name
- SCION MEDICAL TECHOLOGIES, LLC
- Labeler DUNS
- 078473721
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 4
- Public Version Date
- 2021-03-08
- Public Version Status
- Update
- Public Device Record Key
- 516b084b-4c2d-4f76-953e-ca8273f90435
Device Description
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
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47540 | Soft-tissue biopsy needle, single-use | A 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00866479000152 | GS1 |