Coned Heparin Needles

Basic Information

• Brand Name: Coned Heparin Needles
• Primary DI: B033KS400440
• Version / Model: KS-4004-4
• Catalog Number: KS-4004-4
• Company Name: Kapp Surgical Instrument Co.
• Labeler DUNS: 004171112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-14
• Public Version: 1
• Public Version Date: 2023-06-22
• Public Version Status: New
• Public Device Record Key: 9605940f-4852-4966-9007-cf9c1be13281

Device Description

Coned Heparin Needles – Size 04 - 4in

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64113	Vascular irrigation cannula, peripheral	A sterile, rigid tube designed to be surgically inserted, temporarily, into a peripheral blood vessel to function as a channel for the transport of irrigation fluid (e.g., saline, heparin solution) during open vascular surgery. It is typically made of metal with a shaped/bulbous tip (e.g., cone-, olive-shaped) and may be intended to be bent into shape; as it is a rigid device it is not intended to be advanced more than a minimal distance within the lumen of the blood vessel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B033KS400440	HIBCC

Customer Contacts

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