NA

Basic Information

• Brand Name: NA
• Primary DI: 10810030860294
• Version / Model: MCM154
• Catalog Number: MCM154
• Company Name: MID CENTRAL MEDICAL CORP.
• Labeler DUNS: 076907973
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-01
• Public Version: 1
• Public Version Date: 2020-09-09
• Public Version Status: New
• Public Device Record Key: 625dd9cd-44fc-4022-b567-0382b468ca77

Device Description

Stand Alone leg Prep. This is the new stand alone leg prep from Mid Central Medical. There are many types of leg preppers in the industry that mount directly to the surgical table rail and support patients lower limbs. However, these all attach to the table and are limited in positioning. The stand alone leg prep can be used next to the table just as most others are used but can also be placed independently away from the table for various types of cases. Another great use for this leg prep is when surgery is performed on a stretcher or gurney instead of an OR Table. There is no rail on the stretcher to accommodate the standard leg prep but the stand alone leg prep is a great fit! Can be used in infinite positions for arms and legs, whatever the procedure. With rotating support, pretty much any position can be achieved.

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: Yes
• 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55836	Leg procedure positioner	A 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). 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	10810030860294	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	19	Inch
Width	18.75	Inch
Height	42.25	Inch