DEVICE: coDiagnostiX (D835CODX1)
Device Identifier (DI) Information
coDiagnostiX
10
In Commercial Distribution
Dental Wings GmbH
10
In Commercial Distribution
Dental Wings GmbH
Dental surgery treatment planning software
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
| DZJ | Driver, Wire, And Bone Drill, Manual |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -29 and 60 Degrees Celsius |
| Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure: between 12 and 106 KiloPascal |
| Special Storage Condition, Specify: Controlled moisture (no condensation) |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ac3a6117-0d8b-4a10-a84e-69b15af5d97c
July 27, 2022
2
July 20, 2021
July 27, 2022
2
July 20, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| D835CODX200 | 1 | D835CODX1 | In Commercial Distribution | ||
| D835CODX201 | 10 | D835CODX1 | In Commercial Distribution | ||
| D835CODX202 | 40 | D835CODX1 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-448-8168
coDiagnostiX.Support@dental-wings.com
coDiagnostiX.Support@dental-wings.com