Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: G586E7412490
• Version / Model: E7412-49
• Catalog Number: E7412-49
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-18
• Public Version: 1
• Public Version Date: 2023-12-26
• Public Version Status: New
• Public Device Record Key: d1d65a2b-ed6e-4c3f-8ff8-fa8a2e2ac8c3

Device Description

west lacrimal sac gouge, 6.0 mm wide, 7 1/2" (19.0 cm)

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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAQ	GOUGE, NASAL, ENT	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35914	Nasal gouge	A single-bladed, hand-held manual surgical instrument designed to cut and shape the bone and cartilage of the nose during ear/nose/throat (ENT) surgery. It typically comprises a handle proximally which becomes a shaft that terminates in a convex profile with a sharp, semi-lunar, bevelled cutting edge to facilitate tissue removal. It is typically made of high-grade stainless steel as a one-piece instrument and is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G586E7412490	HIBCC

Customer Contacts

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