EPIX Conical Reamer

Basic Information

• Brand Name: EPIX Conical Reamer
• Primary DI: B2215000001500
• Version / Model: 5000-00150
• Catalog Number: 5000-00150
• Company Name: Epix Orthopaedics Inc.
• Labeler DUNS: 084913303
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-05
• Public Version: 1
• Public Version Date: 2019-03-13
• Public Version Status: New
• Public Device Record Key: 76e690a3-9247-4708-ab38-9351790b8a10

Device Description

Reamer

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: 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
HTO	REAMER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37868	Surgical power tool system handpiece, reaming, pneumatic	A hand-held, pneumatically-powered device intended to provide torque specifically for reaming during surgical procedures. The device typically includes a chuck or collet to grip a reamer (e.g., an orthopaedic intramedullary canal reamer), and it usually provides a high torque for heavy reaming; the reaming endpiece is not included. The device is usually cannulated to allow for use of a guidewire. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B2215000001500	HIBCC

Customer Contacts

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