Medtronic Reusable Instruments

Basic Information

• Brand Name: Medtronic Reusable Instruments
• Primary DI: 00673978145372
• Version / Model: X0797-035
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Labeler DUNS: 830350380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-07
• Public Version: 1
• Public Version Date: 2022-10-17
• Public Version Status: New
• Public Device Record Key: e2096281-d42b-4b12-a1f1-4138ae89e3f8

Device Description

PROV CRIMP W/ MOD THUMB LEVER

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
44799	Internal spinal fixation system cable crimper	A scissors-like, heavy-duty, hand-held manual surgical instrument specifically designed to compress (pinch) fixation crimps that are applied to spinal fixation cable(s). The device is used in conjunction with a cable tensioner to lock into final position the cables used to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically designed to be operated by a surgeon with the cable(s) in situ. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00673978145372	GS1

Customer Contacts

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