CARDIOPLEGIA NEEDLE

Basic Information

• Brand Name: CARDIOPLEGIA NEEDLE
• Primary DI: B099280074930
• Version / Model: 2800-7493
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 6
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 9695dedc-b41d-46c4-bbd7-547cd1c49799
• Distribution End Date: 2018-09-22

Device Description

HEARTLINE CARDIOPLEGIA NEEDLE

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: Yes
• 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", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44136	Pericardiocentesis needle, reusable	A sharp bevel-edged, hollow tubular metal instrument specifically designed for the puncture of the pericardial cavity for the aspiration (removal) of fluids (pericardiocentesis). The device is typically long and rigid enough to penetrate the pericardium (e.g., 10 to 18 centimetres in length). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B099280074930	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.5mm 12 1/2"