LOADING CONE

Basic Information

• Brand Name: LOADING CONE
• Primary DI: 00192896096080
• Version / Model: 508-570
• Catalog Number: 508-570
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-08
• Public Version: 1
• Public Version Date: 2019-05-16
• Public Version Status: New
• Public Device Record Key: 3ed74376-1e32-4a8f-8311-4c7580d4849e

Device Description

LOADING CONE

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: 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
FHN	Ligator, Hemorrhoidal	Gastroenterology, Urology	876.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35157	Haemorrhoid ligator	A hand-held manual surgical instrument designed to deploy a ligature (e.g., a latex rubber band) to internal haemorrhoids for their removal through blood flow occlusion. It is typically made of high-grade stainless steel, and has a long shaft with a profiled clamp or grip at the distal end for holding multiple ligatures. The surgeon mechanically operates the distal clamp or grip with a handle(s) to release and deploy the ligatures as needed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896096080	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	12	Millimeter