MAGNETIC PROBE

Basic Information

• Brand Name: MAGNETIC PROBE
• Primary DI: B099280074800
• Version / Model: 2800-7480
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-26
• Public Version: 6
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: b06b2d96-a739-4986-905d-6ca9cb6d51e3
• Distribution End Date: 2018-09-22

Device Description

HEARTLINE MAGNETIC PROBE

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
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62044	Sharp surgical instrument retrieval magnet	A non-sterile, magnetic device intended to be used primarily within an operating room (OR) to pick up metallic instruments/devices (e.g., needles, blades) that have been dropped/mislaid on the floor. It is a non-powered device that includes a fixed magnetic rod/axle with wheels connected to long handle, whereby small, typically sharp, metallic instruments are picked up by magnetism. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B099280074800	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	13.75	Inch