BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183527501
• Version / Model: BR44-19518
• Catalog Number: BR44-19518
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-26
• Public Version: 1
• Public Version Date: 2024-12-04
• Public Version Status: New
• Public Device Record Key: a913d179-a83d-4e72-ba65-7d8238dca591

Device Description

PAPARELLA Fenestrometer, #13, 4mm, 6 1/2"

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Ethylene Oxide, Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYJ	Gauge, Measuring	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
39987	Nasal depth gauge, reusable	A manual instrument designed for introduction into and measurement of the nasal cavities and paranasal sinuses during diagnostic and/or surgical procedures. It typically consists of a hand-held, slender, rod-like metallic device with a fine blunt distal end; the device usually includes rings (e.g., 3, 4, 5 mm) with calibrated diameters at its distal end to perform the measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183527501	GS1

Customer Contacts

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