BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183510077
• Version / Model: BR70-43018
• Catalog Number: BR70-43018
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-22
• Public Version: 1
• Public Version Date: 2023-05-30
• Public Version Status: New
• Public Device Record Key: c22921df-43bc-48a8-a998-f142fe300303

Device Description

HANK Uterine Dilator, double-ended, 5.6mm/6mm, size 17/18

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
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11266	Fixed-diameter cervical dilator, reusable	A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183510077	GS1

Customer Contacts

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