MEDENTiKA

Basic Information

• Brand Name: MEDENTiKA
• Primary DI: 04251574841476
• Version / Model: 6-13-01
• Catalog Number: 6-13-01
• Company Name: MEDENTiKA GmbH
• Labeler DUNS: 537555497
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-20
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 44730c69-79fc-4ecc-a7dc-69acdbf2bbe4

Device Description

Ratchet surgical

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44901	Dental torque wrench	A hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial marker (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	EMKA613019	HIBCC
Primary	04251574841476	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			compatible with Medentika