CEKA & PRECI-LINE ATTACHMENTS

Basic Information

• Brand Name: CEKA & PRECI-LINE ATTACHMENTS
• Primary DI: 14260576942279
• Version / Model: RE H 16
• Catalog Number: RE H 16
• Company Name: Alphadent NV
• Labeler DUNS: 283174985
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2021-03-30
• Public Version: 1
• Public Version Date: 2021-04-07
• Public Version Status: New
• Public Device Record Key: bd284868-3cc3-42d4-aa89-f9e69dbcf3e8

Device Description

REVAX M2 SOLDERING ACCESSORY 2 PCS

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: MR Safe
• Direct Marking Exempt: Yes
• 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
EGG	ATTACHMENT, PRECISION, ALL	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45714	Fixture/appliance dental drill bit, reusable	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04260576942272	GS1
Primary	14260576942279	GS1

Customer Contacts

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