Neoss Implant System

Basic Information

• Brand Name: Neoss Implant System
• Primary DI: 05060440331718
• Version / Model: 41119
• Catalog Number: 41119
• Company Name: Neoss Ltd
• Labeler DUNS: 216693627
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-05
• Public Version: 3
• Public Version Date: 2023-06-27
• Public Version Status: Update
• Public Device Record Key: 740ab43b-e46a-41bc-87a0-a3b110b513b2
• Distribution End Date: 2016-12-31

Device Description

X-ray Planner ProActive Straight Implants

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: No
• Has Manufacturing Date: Yes
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47974	Dental implant x-ray template	A non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060440331718	GS1

Customer Contacts

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