BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183527402
• Version / Model: BR44-00000
• Catalog Number: BR44-00000
• 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: d3ef35d2-1b97-41a0-ab77-6591ff7b3c28

Device Description

SHEA Speculum Holder, overall length 15 3/4"

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
JYK	Holder, Ear Speculum	General, Plastic Surgery	878.1800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33429	ENT speculum holder	A device intended to be used to secure an ear/nose/throat (ENT) speculum in a fixed position to enable a surgeon to remain hands-free during a surgical intervention. The holder is typically fastened to the side rail of the operating table and can be adjusted to a desired position. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183527402	GS1

Customer Contacts

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