Cassi

Primary DI
10866479000135
Brand
Cassi
Company
SCION MEDICAL TECHOLOGIES, LLC
Model
CS2120-NT-1
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
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161234000CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC2016-08-03KNW

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078473721
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00866479000138CassiCS2120-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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
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00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
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