StecoTitanmagnetics®

Basic Information

• Brand Name: StecoTitanmagnetics®
• Primary DI: ESTOI3801X3000
• Version / Model: I.38.01.X300
• Catalog Number: I.38.01.X300
• Company Name: steco-System-Technik GmbH & Co KG
• Labeler DUNS: 389566209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-24
• Public Version: 1
• Public Version Date: 2023-08-01
• Public Version Status: New
• Public Device Record Key: 4e9899da-0d0f-4d57-88f7-8767d95cce20

Device Description

Titanmagnetics® Insert X-Line D4.8/H3.0 for Nobel Replace Implant ø3.5 -> For further information visit steco.de

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: MR Conditional
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGG	Attachment, Precision, All	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38578	Magnetic dental precision attachment	A device with magnetic properties designed for fixation of a removable dental prosthesis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	ESTOI3801X3000	HIBCC

Customer Contacts

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