Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331131028
• Version / Model: NS30804
• Catalog Number: NS30804
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-10
• Public Version: 1
• Public Version Date: 2022-11-18
• Public Version Status: New
• Public Device Record Key: e1c52902-a91c-471d-adda-597edf0411d5

Device Description

trumpet valvetrumpet valve

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: No
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30077	Ear trumpet	A purely acoustic device shaped like a trumpet used to improve hearing sensation in persons with hearing impairment. The wider end of the device receives sound waves and channels them to the narrow end which is held at the entrance of the ear canal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331131028	GS1

Customer Contacts

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