BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183503697
• Version / Model: BR02-18090
• Catalog Number: BR02-18090
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-25
• Public Version: 1
• Public Version Date: 2020-09-02
• Public Version Status: New
• Public Device Record Key: 96fa37e6-9c39-4cd2-9398-7151b0aeff8f

Device Description

ZIEGLER Head Mirror, 3 1/2" (90mm)

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKF	Mirror, Headband, Ophthalmic	Ophthalmic	886.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32707	Ophthalmic head reflector	A head-worn ophthalmic device consisting of a circular concave mirror attached to a headband worn by an examiner, designed to reflect light onto the eye of a patient to allow examination of the eye and its associated structures. This is a reusable device.	No	Active
34637	Head reflector	A head-worn device consisting of a circular concave mirror (reflector) attached to a headband designed to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient. The examiner wears the device on his/her head, places the reflector in front of one eye, and views the site through a small hole in the centre of the reflector. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183503697	GS1

Customer Contacts

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