ChibaSono

Basic Information

• Brand Name: ChibaSono
• Primary DI: 14048223020392
• Version / Model: 530S070100
• Catalog Number: 530S070100
• Company Name: Pajunk GmbH Medizintechnologie
• Labeler DUNS: 317654283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2021-03-16
• Public Version Status: Update
• Public Device Record Key: 427f859f-5704-4346-a67c-51f5611c12af
• Distribution End Date: 2025-03-15

Device Description

ChibaSono 22G x 100mm US-tip, with graduation and wings

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
FCG	Biopsy needle	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
Primary	14048223020392	GS1
Unit of Use	04048223020395	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]