coDiagnostiX

Basic Information

• Brand Name: coDiagnostiX
• Primary DI: D835CODX1
• Version / Model: 10
• Company Name: Dental Wings GmbH
• Labeler DUNS: 342721295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-20
• Public Version: 2
• Public Version Date: 2022-07-27
• Public Version Status: Update
• Public Device Record Key: ac3a6117-0d8b-4a10-a84e-69b15af5d97c

Device Description

Dental surgery treatment planning software

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40935	Diagnostic x-ray digital imaging system workstation	A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D835CODX200	HIBCC		1	In Commercial Distribution
Primary	D835CODX1	HIBCC
Package	D835CODX201	HIBCC		10	In Commercial Distribution
Package	D835CODX202	HIBCC		40	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 12 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Controlled moisture (no condensation)