Novo Surgical

Basic Information

• Brand Name: Novo Surgical
• Primary DI: G586C6681660
• Version / Model: C6681-66
• Catalog Number: C6681-66
• 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: 81469be7-dde4-4475-9ab5-32e4f8016397

Device Description

jacobson endarterectomy spatula, semi-sharp blade 1.0 mm x 10.0 mm, 7" (17.5 cm), straight blade

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
GAF	SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38127	Vascular spatula	A hand-held surgical instrument designed to be used within the vasculature (a blood vessel) to scrape, manipulate, and remove tissue therein. It typically made of high-grade stainless steel and consists of a flat blunt blade (no sharp edges) that is either single-ended or double-ended (a blade at either end). It is available with a variety of blade designs, e.g., curved and spoon-shaped or curved and straight. The handle can be placed proximally or be formed from its middle section and may be more prominent/serrated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G586C6681660	HIBCC

Customer Contacts

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