Arm (Articulated Arm for Radial Clamp)

Basic Information

• Brand Name: Arm (Articulated Arm for Radial Clamp)
• Primary DI: 00810019931888
• Version / Model: MRS-115
• Company Name: Bradshaw Medical, Inc.
• Labeler DUNS: 621830582
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-08
• Public Version: 1
• Public Version Date: 2025-08-18
• Public Version Status: New
• Public Device Record Key: 69fca43e-2e7e-4646-a44a-b286b5e41096

Device Description

The Arm (Articulated Arm for Radial Clamp) is a non-powered, reusable, hand-held surgical instrument designed for use in orthopedic surgery. Its primary function is to provide stable, adjustable support for other manual surgical instruments and devices used to manipulate tissue during orthopedic procedures. The device is an "assist arm" that effectively serves as an extension of the surgical team, holding orthopedic instruments like retractors, awls, or probes in a fixed position, thereby enhancing surgical efficiency and precision in orthopedic applications.

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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37041	Breathing circuit tube holder	A device designed primarily to hold the breathing circuit tubing that carries gases from a ventilator and/or anaesthesia system to and from the patient. It is typically fixed to the ventilator/anaesthesia system, but can also be fixed to the patient's bed or medical device service rails (e.g., a wall rail). It is made of metal and plastic materials with adjustable jointed sections. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810019931888	GS1