FRANSEEN

Basic Information

• Brand Name: FRANSEEN
• Primary DI: 08053329372176
• Version / Model: FR22160-01
• Company Name: MEDAX SRL UNIPERSONALE
• Labeler DUNS: 440211428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-02
• Public Version: 2
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: a8b7331f-b1e2-486f-9ef3-3acbf92ea49d

Device Description

FRANSEEN fine aspiration needle 22G x 160MM

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
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	18053329372173	GS1		20	In Commercial Distribution
Primary	08053329372176	GS1

Premarket Submissions

Submission Number	Supplement Number
K181803	000