CePo Center Point Drils

Basic Information

• Brand Name: CePo Center Point Drils
• Primary DI: 07350081495206
• Version / Model: MR-1145
• Catalog Number: MR-1145
• Company Name: Dentatus AB
• Labeler DUNS: 355803412
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-10
• Public Version: 3
• Public Version Date: 2018-11-22
• Public Version Status: Update
• Public Device Record Key: 9a803aa5-2e99-4c33-98c4-775e806c31bf

Device Description

2x Center Point Profile Drills for implant diameter =2.2 - System 2

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJL	Bur, Dental	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32390	Fluted surgical drill bit, reusable	A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350081495206	GS1

Customer Contacts

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