Cassi

GUDID 10866479000128

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

Soft-tissue biopsy needle, single-use

• Primary Device ID: 10866479000128
• NIH Device Record Key: d9899999-8a87-406f-82a6-bf7dd7e5edc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cassi
• Version Model Number: CS2100-NT-1
• Company DUNS: 078473721
• Company Name: SCION MEDICAL TECHOLOGIES, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866479000121 [Primary]
GS1	10866479000128 [Package]; Contains: 00866479000121; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161234

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-30

On-Brand Devices [Cassi]

• 00866479000152: The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-
• 00866479000145: The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-
• 10866479000135: The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-
• 10866479000128: The Cassi Rotational Core Biopsy System is used to perform biopsy procedures on multiple patient