SONTEC INTRANASAL OSTEOTOME

Basic Information

• Brand Name: SONTEC INTRANASAL OSTEOTOME
• Primary DI: 00192896042711
• Version / Model: 475-746
• Catalog Number: 475-746
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-12
• Public Version: 1
• Public Version Date: 2018-10-15
• Public Version Status: New
• Public Device Record Key: 7307f1f1-c9cc-44a1-a819-24a27805c626

Device Description

SONTEC INTRANASAL OSTEOTOME

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
HWM	OSTEOTOME	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12846	Plastic surgery osteotome	A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896042711	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7	Inch
Device Size Text, specify			7 Millimeter Tip