SONTEC EAR RASPATORY SET

Basic Information

• Brand Name: SONTEC EAR RASPATORY SET
• Primary DI: 00192896042551
• Version / Model: 475-615
• Catalog Number: 475-615
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-14
• Public Version: 2
• Public Version Date: 2018-12-07
• Public Version Status: Update
• Public Device Record Key: 9ff05cf0-cda9-44e4-b99e-2695ad759eda

Device Description

SONTEC EAR RASPATORY SET

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: 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: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYY	RASP, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35295	Middle ear file/rasp	A hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the distal working end designed to scrape and smooth the bony structures of the middle ear. It is typically used during ear/nose/throat (ENT) or plastic surgery; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896042551	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7.25	Inch