BR Surgical, LLC

Basic Information

• Brand Name: BR Surgical, LLC
• Primary DI: 00840183500320
• Version / Model: BR66-16820
• Catalog Number: BR66-16820
• Company Name: BR Surgical, LLC
• Labeler DUNS: 134781207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-23
• Public Version: 1
• Public Version Date: 2022-12-01
• Public Version Status: New
• Public Device Record Key: 562196c9-9667-41f1-a65a-495c73def344

Device Description

MATHIEU Foreign Body/IUD Removal Forceps, serrated, 8"

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
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61480	Intrauterine device thread extractor	A hand-held manual instrument intended to be used to locate and extract the threads of an intrauterine device (IUD) through the cervical os from within the uterine cavity. It is made of plastic materials and typically takes the form of a shaft with hook-like notches along the distal portion. It may subsequently be used to extract the IUD. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840183500320	GS1

Customer Contacts

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