NA

Basic Information

• Brand Name: NA
• Primary DI: 10810030860324
• Version / Model: MCM158
• Catalog Number: MCM158
• 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: b139bf5e-33e4-4666-9087-7c488d222dd8

Device Description

Pediatric single Loop Leg Prep is made from 3/8” 304 grade Stainless Steel and a soft molded pad. Used for prepping of the leg of children for surgery. Attaches to the side rail of operating table with clamp such as clark socket(sold separately) and any other clamp that accepts a 3/8" round rod. Depending on the clamp, this leg prepper can be adjusted in many different ways. Includes 1 soft molded pad. Replacements MCM156 (sold separately). .

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	10810030860324	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	0.375	Inch
Depth	9.375	Inch
Height	38.375	Inch