Response 5.5/6.0

Basic Information

• Brand Name: Response 5.5/6.0
• Primary DI: 00840194495202
• Version / Model: 01-1300-6524
• Catalog Number: 01-1300-6524
• Company Name: ORTHOPEDIATRICS CORP.
• Labeler DUNS: 796416191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-31
• Public Version: 1
• Public Version Date: 2026-01-08
• Public Version Status: New
• Public Device Record Key: 350b8fd0-b965-4fad-9c1a-3177225b064a

Device Description

5.5/6.0 Response Quick-Draw Reducer - Removal Tool

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: 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: 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
LXH	Orthopedic manual surgical instrument	Orthopedic	888.4540	1

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	00840194495202	GS1

Customer Contacts

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