Neoss Implant System

Basic Information

• Brand Name: Neoss Implant System
• Primary DI: 05060440331824
• Version / Model: 41143
• Catalog Number: 41143
• Company Name: Neoss AB
• Labeler DUNS: 509583543
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 5
• Public Version Date: 2021-04-01
• Public Version Status: Update
• Public Device Record Key: b63749e5-52c5-4d14-9854-1fd2dc9908da

Device Description

Drill Stop 9 mm Ø2.2, 3.0, 3.4, 3.9 and 4.4 mm

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZA	Drill, Dental, Intraoral	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65191	Dental instrument depth limiter	A small device in the form of a ring or cylinder intended to be placed on a surgically-invasive dental instrument or power tool endpiece (e.g., file/rasp, drill bit, reamer) to limit the depth of insertion typically into the tooth or bone; it is typically made of polymer materials (e.g., silicone). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060440331824	GS1

Customer Contacts

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