Guide Surgery set, SL

Basic Information

• Brand Name: Guide Surgery set, SL
• Primary DI: E219J506543071
• Version / Model: J5065.4307
• Catalog Number: J5065.4307
• Company Name: ALTATEC GmbH
• Labeler DUNS: 322018193
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: 1ad1fbf2-7da9-4805-9bdf-ee23479ce9ee

Device Description

Guide Surgery set, SL, internal irrigation Ø 4.3 mm L 7.0 mm Ø 4.3 L 7.0

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
45697	Fixture/appliance dental drill bit, single-use	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 motorized handpiece or other power source that provides rotation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E219J506543071	HIBCC

Customer Contacts

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