Medtronic Reusable Instruments

Basic Information

• Brand Name: Medtronic Reusable Instruments
• Primary DI: 00673978047768
• Version / Model: 825-220
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-26
• Public Version: 2
• Public Version Date: 2023-12-08
• Public Version Status: Update
• Public Device Record Key: 737d7900-552b-4346-a2ca-9150e7c15a0b

Device Description

INSTRUMENT 825-220 CABLE CRIMPER

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
HXQ	CRIMPER, PIN	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44798	Internal spinal fixation system cable crimp	An implantable device intended to be used as part of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is used to lock implanted spinal fixation cable(s) after the surgeon has appropriately tensioned them. It is made of high-grade stainless steel alloy or medical grade titanium (Ti), and is locked around the cable with a dedicated cable crimper.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673978047768	GS1

Customer Contacts

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