DEVICE: coDiagnostiX (D835CDX1)

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Device Record History
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Device Identifier (DI) Information
coDiagnostiX
9
Not in Commercial Distribution

Dental Wings GmbH
D835CDX1
HIBCC
August 31, 2021
1
342721295 *Terms of Use
Dental implant planning software
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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
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FDA Product Code

[?]
Product Code Product Code Name
LLZ System, Image Processing, Radiological
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K130724 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Controlled moisture (no condensation)
Storage Environment Atmospheric Pressure: between 12 and 106 KiloPascal
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -29 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
68940839-990a-46e5-a579-b51ab3683d2a
August 31, 2021
7
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D835CDX202 40 D835CDX1 2021-08-31 Not in Commercial Distribution
D835CDX201 20 D835CDX1 2021-08-31 Not in Commercial Distribution
D835CDX200 1 D835CDX1 2021-08-31 Not in Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
888-856-6997
coDiagnostiX.Support@dental-wings.com
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