Praxis Medical CytoCore and CytoCore Luer Adapters

Basic Information

• Brand Name: Praxis Medical CytoCore and CytoCore Luer Adapters
• Primary DI: 00860003935866
• Version / Model: C0025L
• Company Name: PRAXIS MEDICAL LLC
• Labeler DUNS: 939493362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-06-07
• Public Version: 1
• Public Version Date: 2022-06-15
• Public Version Status: New
• Public Device Record Key: f3894c8f-3c20-438a-83fd-b287f5b2ded0

Device Description

CytoCore device (DI 00860003935804) with extra luer adapters pouch (DI 00860003935835)

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: 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
64880	Biopsy syringe holder, single-use	A hand-operated device designed to hold a biopsy syringe to facilitate precision aspiration of a tissue specimen through a biopsy needle. The holder is typically made of metal and plastic materials and typically designed as a lightweight, hand-held frame in which the syringe is placed and its piston withdrawn using a sliding handle in the frame; a stopper may be included to prevent further aspiration at a predetermined point. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860003935866	GS1
Unit of Use	00860003935835	GS1

Premarket Submissions

Submission Number	Supplement Number
K200278	000