CytoCut

Basic Information

• Brand Name: CytoCut
• Primary DI: 08052440108190
• Version / Model: PB2015
• Catalog Number: PB2015
• Company Name: M.D.L. S.R.L.
• Labeler DUNS: 447228586
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-04
• Public Version: 7
• Public Version Date: 2021-05-27
• Public Version Status: Update
• Public Device Record Key: 299ccf0c-5053-47a1-bc3e-1005d744b45e
• Distribution End Date: 2021-05-13

Device Description

10 CS - DISPOSABLE CHIBA NEEDLE 20G X 150MM FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08052440108725	GS1		10	Not in Commercial Distribution	2021-05-13
Primary	08052440108190	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	20	Gauge
Length	150	Millimeter