Paradigm

Basic Information

• Brand Name: Paradigm
• Primary DI: 00850042604229
• Version / Model: 1200019
• Catalog Number: 1200019
• Company Name: Proprio, Inc.
• Labeler DUNS: 010254854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-21
• Public Version: 2
• Public Version Date: 2026-01-13
• Public Version Status: Update
• Public Device Record Key: 90fd2689-3f17-4644-9e24-b7abff80ef2b

Device Description

Paradigm DRF Ratcheting Clamp

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLO	Orthopedic Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64363	Assistive gripping/twisting tool, reusable	A hand-held manual device intended to be used to grip and/or twist medical device and/or household items, usually to lock/unlock, turn on and off, and/or open and close components. It may or may not be intended to be a disability-assistive tool and it might have one or more gripping component(s) or spanner-like ends, and a lever or dial for twisting/turning. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850042604229	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K243258	000
K250879	000
K252950	000