HEARTLINE COOLEY SCISSORS

Basic Information

• Brand Name: HEARTLINE COOLEY SCISSORS
• Primary DI: B09928002350
• Version / Model: 2800-235
• 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: 8
• Public Version Date: 2018-12-21
• Public Version Status: Update
• Public Device Record Key: e7015acf-4c27-4520-a3b7-8cd87758bfa4
• Distribution End Date: 2018-09-22

Device Description

HEARTLINE COOLEY SCISSORS CURVED BLADE BLUNT TIP SQUEEZE HANDLE

Device Characteristics

• Single Use: No
• 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: 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44354	Vascular scissors	A hand-held, manual surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. Often referred to as micro-scissors, it is a metallic device with two small pivoted blades which cut with a shearing action. The blades are often pointed to penetrate the vessel wall, may be straight, curved sideways, or acutely angled, and may include carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B09928002350	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152400	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			30° Blade
Device Size Text, specify			5mm Shaft
Length	24.2	Centimeter