Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331162848
• Version / Model: E1024-11
• Catalog Number: E1024-11
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-13
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: d14239d0-a396-4f5b-b51e-acad3c1960ba

Device Description

skillern sinus probe, malleable, w/ cm graduations at 5.0 cm, 7.0 cm & 9.0 cm, 6 1/2" (16.5 cm)

Device Characteristics

• Single Use: Yes
• 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
KAK	Probe, Ent	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33400	Mastoid gauge	A manual surgical instrument designed for introduction into and calibration of the mastoid bone antrum during surgical procedures (e.g., mastoidectomy). It is typically a slender, hand-held, calibrated (e.g., in millimetres) metallic device with an angled blunt distal end (also known as a searcher or seeker). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331162848	GS1

Customer Contacts

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