Evry

Basic Information

• Brand Name: Evry
• Primary DI: 00670082000450
• Version / Model: SYN-0777
• Company Name: Synaptive Medical Inc
• Labeler DUNS: 203061833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-05
• Public Version: 2
• Public Version Date: 2023-10-24
• Public Version Status: Update
• Public Device Record Key: eb592cd3-730a-4002-97d9-12b8011dc185

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	892.1000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37656	Extremity MRI system, superconducting magnet	A diagnostic magnetic resonance imaging (MRI) system employing superconducting magnet technology specifically designed to image only the head and neck or limbs. Extremity imaging systems are typically closed bore designs with cylindrical or rectangular bore openings but can be "open" bore designs. They include MRI systems with conventional extremity imaging capabilities, conventional systems capable of performing spectroscopy or other real-time imaging procedures necessary for interventional and therapeutic MRI applications, and dedicated MR spectroscopy systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10670082000495	GS1		1	In Commercial Distribution
Primary	00670082000450	GS1