Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331179761
• Version / Model: E8556-31
• Catalog Number: E8556-31
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-14
• Public Version: 1
• Public Version Date: 2022-11-22
• Public Version Status: New
• Public Device Record Key: 0c4101c3-a2ef-49d3-b5fd-3b4b691e9ea1

Device Description

jako laryngeal probe, length, working: 8 5/8" (22.0 cm), overall: 11 5/8" (30.0 cm), straight

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	00842331179761	GS1

Customer Contacts

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