Heartline Knot Pusher

Basic Information

• Brand Name: Heartline Knot Pusher
• Primary DI: 00192896113015
• Version / Model: 2800-404
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-31
• Public Version: 1
• Public Version Date: 2022-06-08
• Public Version Status: New
• Public Device Record Key: 709b4a1d-d4bd-4093-ba74-3a9dfa623bef

Device Description

Heartline Knot Pusher Forceps - Push To Open Shaft 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: Yes
• 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
45716	Suture knot pusher, reusable	A hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896113015	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152400	000

Device Sizes

Type	Value	Unit	Text
Length	25	Centimeter
Device Size Text, specify			Shaft 5 Millimeter Diameter