BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183501280
• Version / Model: BR68-00278
• Catalog Number: BR68-00278
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-22
• Public Version: 1
• Public Version Date: 2022-11-30
• Public Version Status: New
• Public Device Record Key: 8e1e9ccf-e69c-4a98-aa5c-a967b855ca92

Device Description

HINKLE-JAMES Rectal Speculum, large, 18x54mm, 5-1/3"

Device Characteristics

• Single Use: Yes
• 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
FFQ	Speculum, Rectal	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35351	Rectal speculum	A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183501280	GS1

Customer Contacts

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