Paradigm

Basic Information

• Brand Name: Paradigm
• Primary DI: 30845854082953
• Version / Model: PRLLB
• Catalog Number: PRLLB
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 2
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: e4f7f4f4-5195-4553-9fb2-e249ac202021

Device Description

Paradigm Revolution Left Leg Boom

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
HST	Apparatus, traction, non-powered	Orthopedic	888.5850	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
Direct Marking	10845854082959	GS1
Primary	30845854082953	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY
• Type: Storage Environment Temperature
• Temperature Range: 50 – 77 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius