EVOS Cabling System

Basic Information

• Brand Name: EVOS Cabling System
• Primary DI: 00191083003993
• Version / Model: 56-71175677
• Catalog Number: 71175677
• Company Name: Pioneer Surgical Technology, Inc.
• Labeler DUNS: 793384496
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-01
• Public Version: 6
• Public Version Date: 2023-12-19
• Public Version Status: Update
• Public Device Record Key: fc262a17-6c5d-4e7e-aa5b-6f9d3bb6fa83

Device Description

Cable Crimper

Device Characteristics

• Single Use: Yes
• 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
HXN	APPLIER, CERCLAGE	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32879	Orthopaedic wire crimper	A hand-held manual surgical instrument designed like wire-closing forceps and used to bend wire or cerclage. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00191083003993	GS1

Customer Contacts

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