Novo Surgical Inc.

Basic Information

• Brand Name: Novo Surgical Inc.
• Primary DI: 00842331138683
• Version / Model: E8306-25
• Catalog Number: E8306-25
• Company Name: NOVO SURGICAL, INC.
• Labeler DUNS: 033029433
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: cb4cc983-10be-4252-b5cb-adf997bd0b42

Device Description

tonsil needle, 23 gauge, w/ luer lock, 4 1/4" (10.8 cm), 45 degree angle, 13.0 mm needle extension

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
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12732	Airway needle	A sterile, sharp bevel-edged, hollow tubular metal instrument typically used to pierce the throat through to the trachea to establish airway patency. It is especially used to perform cricothyroidotomy in emergency cases of respiratory obstruction. It is typically used by emergency medical services (EMS). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842331138683	GS1

Customer Contacts

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