BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00857556008314
• Version / Model: BR970-2912-302
• Catalog Number: BR970-2912-302
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-15
• Public Version: 3
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 85247c97-bc55-48f3-bfc9-977d089d3916

Device Description

Hysteroscope, autoclavable, Ø 2.9mm, 12º, 302mm

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Hydrogen Peroxide", "Ethylene Oxide", "Moist Heat or Steam Sterilization", "High-level Disinfectant"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAJ	Cystoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
HIH	HYSTEROSCOPE (AND ACCESSORIES)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36628	Rigid optical hysteroscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is typically used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857556008314	GS1

Customer Contacts

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