Paradigm

Basic Information

• Brand Name: Paradigm
• Primary DI: 30845854083028
• Version / Model: PRLB
• Catalog Number: PRLB
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 2
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: d23a0b91-7f68-4dde-8ddd-f4bfd2571468

Device Description

Paradigm Revolution Large Boot, Pair

Device Characteristics

• Single Use: No
• 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: Yes
• 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
HST	Apparatus, traction, non-powered	Orthopedic	888.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46509	Traction boot	An orthopaedic device designed as an open boot that is attached and tightly secured with laces or straps to the foot or both feet of the patient so that traction can be applied to the patient's body. It is typically used during an orthopaedic surgical trauma intervention when traction is being applied to a patient's leg or legs when broken leg bones are being drawn apart, repositioned, and set to the correct position, or in conjunction with a traction table for the application of traction to the patient's spine. It is available in various foot sizes and has a solid sole construction that can be securely attached/locked to other components of the table. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	10845854083024	GS1
Primary	30845854083028	GS1

Customer Contacts

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

Storage Conditions

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