COMPLETE-CHIBA MR

Basic Information

• Brand Name: COMPLETE-CHIBA MR
• Primary DI: 08033959222621
• Version / Model: COMPLETE-CHIBA MR
• Catalog Number: CCH2011MR
• Company Name: STERYLAB SRL
• Labeler DUNS: 439659574
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-02
• Public Version: 2
• Public Version Date: 2019-10-11
• Public Version Status: Update
• Public Device Record Key: bbd20776-399e-4b56-a8eb-0a8ca6a61636

Device Description

Chiba type needle with quincke point 20 G; 11 cm

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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
Package	18033959222628	GS1		5	In Commercial Distribution
Primary	08033959222621	GS1

Premarket Submissions

Submission Number	Supplement Number
K051506	000