WELLENSCHLIFF NASAL SAW

Basic Information

• Brand Name: WELLENSCHLIFF NASAL SAW
• Primary DI: 00192896078291
• Version / Model: 345-249
• Catalog Number: 345-249
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 2
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: 2e9e2cb0-4b05-495a-90b7-e2b1a6b85a98

Device Description

WELLENSCHLIFF NASAL SAW STRAIGHT TIP ROUND END

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
KBC	Saw, Nasal	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42900	Nasal saw	A hand-held manual surgical instrument designed for cutting bone and/or cartilage in the nose. It is typically a one-piece metal instrument made of high-grade surgical steel with a handle at the proximal end and a long, thin, serrated blade at the distal end with the cutting teeth set in a straight line, a rounded nose at the tip, and a smooth edge on the top side of the blade to protect tissue not intended to be cut. The instrument is typically used in plastic (i.e., rhinoplasty) and reconstructive procedures of the nose. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896078291	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7.5	Inch