Epoca

Basic Information

• Brand Name: Epoca
• Primary DI: 10886982002907
• Version / Model: SD100.004
• Catalog Number: SD100004
• Company Name: SYNTHES (U.S.A.) LP
• Labeler DUNS: 832637081
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 5
• Public Version Date: 2018-12-07
• Public Version Status: Update
• Public Device Record Key: 29271143-41d4-47f7-8d38-1a82892de3ef
• Distribution End Date: 2018-12-01

Device Description

REPLACEMENT SCREW FOR EPOCA REMOVAL ADAPTER

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
47779	Orthopaedic instrument surgical connector	A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H679SD1000040	HIBCC
Primary	10886982002907	GS1

Customer Contacts

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