BEAR

Basic Information

• Brand Name: BEAR
• Primary DI: G043112510
• Version / Model: 1.12.51
• Catalog Number: 1.12.51
• Company Name: Bear-Ent, LLC
• Labeler DUNS: 123551586
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-11
• Public Version: 1
• Public Version Date: 2023-03-20
• Public Version Status: New
• Public Device Record Key: 6ebf06ff-9427-4e2b-a787-02303fec3fa8

Device Description

Van Alyea Antrum Cannula w Thumb Plate, Strong Curve

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
KAM	Cannula, Sinus	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64292	Paranasal sinus irrigation/aspiration cannula	An atraumatic, non-surgically invasive, hand-operated, single-lumen, rigid or semi-rigid tube designed to be introduced into the sinus cavities, through the nostrils, to function as a conduit for irrigation and aspiration (i.e., capable of both functions) of the sinus cavities during an ENT procedure, typically for clearance. The device may incorporate a handle with a side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G043112510	HIBCC