FDA.reportPublic FDA data

coDiagnostiX

Primary DI
D835CODX1
Brand
coDiagnostiX
Company
Dental Wings GmbH
Model
10
Device description
Dental surgery treatment planning software
Published
2021-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDriver, Wire, And Bone Drill, Manual
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D835CODX200PackageHIBCC1In Commercial Distribution
D835CODX201PackageHIBCC10In Commercial Distribution
D835CODX202PackageHIBCC40In Commercial Distribution
D835CODX1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstationA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Controlled moisture (no condensation)
Storage Environment Atmospheric Pressure12 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-448-8168coDiagnostiX.Support@dental-wings.com

Regulatory Flags#

DUNS number
342721295
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D835CDX1coDiagnostiX92016-09-17
D835CODX200coDiagnostiX102021-07-20
D835CDX202coDiagnostiX92016-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
00817886020394JointsMEDSTRAT, INC.LLZ2021-10-15
00817886020387JointsMEDSTRAT, INC.LLZ2021-09-08
00817886020370JointsMEDSTRAT, INC.LLZ2021-07-30
00817886020363JointsMEDSTRAT, INC.LLZ2021-07-02
00817886020356JointsMEDSTRAT, INC.LLZ2021-06-01
00817886020349JointsMEDSTRAT, INC.LLZ2021-04-05
00817886020332JointsMEDSTRAT, INC.LLZ2021-02-26
00817886020325JointsMEDSTRAT, INC.LLZ2021-01-29
00817886020318JointsMEDSTRAT, INC.LLZ2020-12-11
00817886020301JointsMEDSTRAT, INC.LLZ2020-11-02
00817886020295JointsMEDSTRAT, INC.LLZ2020-10-05
00350227300071FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-09-19
00817886020288JointsMEDSTRAT, INC.LLZ2020-08-31
00817886020226JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020233JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020240JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020257JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020264JointsMEDSTRAT, INC.LLZ2020-08-03
00817886020271JointsMEDSTRAT, INC.LLZ2020-08-03
00350227300064FUSEPATTERSON TECHNOLOGY CENTERLLZ2020-06-02