rematitan®

Basic Information

• Brand Name: rematitan®
• Primary DI: J011240022000
• Version / Model: 240-022-00
• Company Name: DENTAURUM GmbH & Co.KG
• Labeler DUNS: 315427286
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 3
• Public Version Date: 2018-11-19
• Public Version Status: Update
• Public Device Record Key: aeea9653-10ee-4f4d-8166-624337a83336
• Distribution End Date: 2018-11-17

Device Description

rematitan® attachment, 36 °, complete Ti-plastic female part

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EBL	PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS	Dental	872.3740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38580	Sliding dental precision attachment	A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J011240022000	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: No special storage conditions required