Fixation screw

Basic Information

• Brand Name: Fixation screw
• Primary DI: 07290108818215
• Version / Model: NMBS1810
• Catalog Number: NMBS1810
• Company Name: NORIS MEDICAL LTD
• Labeler DUNS: 649340106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-10
• Public Version: 1
• Public Version Date: 2025-11-18
• Public Version Status: New
• Public Device Record Key: 6c4f8049-6bf5-47b9-b1c5-80e6c763bc27

Device Description

Bone Screw D1.8 L10.0mm, Ti.

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: 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
DZA	Drill, Dental, Intraoral	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64372	Dental implantation drilling template stabilization bolt	A threaded bolt with a proximal flange intended to be used with a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation), to temporarily fix the template to a dental implant, immediately following implant introduction. It is intended to pass through the guide hole of the template and screw into the implant (much like a dental abutment); the proximal flange allows the template to be secured. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290108818215	GS1

Customer Contacts

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