Winx®

Basic Information

• Brand Name: Winx®
• Primary DI: 00852126007506
• Version / Model: 12215
• Catalog Number: 12215
• Company Name: APNICURE, INC.
• Labeler DUNS: 008873230
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 95629b9d-a4d5-4060-ad7a-3ba7e2a4549e

Device Description

Winx Data Management Software on USB Drive

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: 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
OZR	Intraoral Pressure Gradient Device	Dental	872.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44105	Physician-practice-management information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data to support the administrative and clinical activities associated with the provision and utilization of physician services and office facilities. It may be used to process insurance claims and prepare patient statements; schedule the physician's time and make patient appointments; and store and retrieve patient records. It is typically installed into a dedicated information system for physician practice management, or existing mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852126007506	GS1

Customer Contacts

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