NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995165147
• Version / Model: Leg Positioner
• Catalog Number: BF351
• Company Name: STERIS CORPORATION
• Labeler DUNS: 036985604
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 3
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 5f86edaf-5264-4a27-9e4f-571b973d41fe
• Distribution End Date: 2023-10-03

Device Description

The Split Leg Positioner includes both Left and Right Leg Supports and provides a safe system for positioning patients for laparoscopic procedures and lower extremity Orthopedic and Vascular procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
BWN	TABLE AND ATTACHMENTS, OPERATING-ROOM	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55836	Leg procedure positioner	A non-powered, patient-contact, preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure), or during patient transfer to an operating table; it is not intended for application of traction forces. It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00724995165147	GS1

Customer Contacts

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